Clinical Study Synopsis

Size: px
Start display at page:

Download "Clinical Study Synopsis"

Transcription

1 Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labelling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare Pharmaceuticals Inc. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare Pharmaceuticals Inc. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Webposting Clinical Trial Results Synopsis Study Sponsor: BSP AG Germany/Bayer Healthcare Pharmaceuticals Study Number: NCT Study Phase: IIIb Study Title: Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 days versus Placebo in the Treatment of Acute Bacterial Sinusitis Therapeutic Area: Primary care Name of Test Product: BAY /moxifloxacin/Avelox Active Ingredient: Moxifloxacin Dosage: 400mg daily Reference Therapy: Not applicable. Dosage: Not applicable. Route of Administration: Oral Placebo: Matching placebo contained microcrystalline cellulose. Treatment Duration: 5 days Study Period: Date of first subjects first visit: 06 Jan 2005 Date of last subjects last visit 18 Mar 2008 Methodology: This was a prospective, multicenter, placebo-controlled, randomized, double-blind, Phase IIIb clinical trial designed to evaluate the efficacy and safety of moxifloxacin as compared with placebo in subjects with ABS. After giving written informed consent, subjects who satisfied all inclusion and exclusion criteria were randomized in a 2:1 ratio to treatment with either moxifloxacin 400 mg QD or matching placebo for 5 days. Subjects were evaluated for efficacy and safety at scheduled visits as follows: During Therapy (Day 3 or Day 4); TOC (Day +1 to +3); Premature Discontinuation; Follow-Up (Days +17 to +21); and Post- Alternative Antibiotic (Days +2 to +4 post-alternative antibiotic). Study Site: The study was conducted at 37 centers in the United States (US). Main Inclusion Criteria: The primary diagnosis for inclusion in the study was ABS. Subjects included in the study were men and nonpregnant women, 18 years of age or older, who had a clinical diagnosis of ABS with signs and symptoms present for 7 days but < 28 days as defined by radiographic and clinical criteria. Radiographic criteria included the presence of either or both of the following on a radiographic paranasal sinus film (Waters view): evidence of air-fluid levels and opacification. Eligible subjects also had the presence of 2 major symptoms (purulent anterior or posterior nasal discharge and unilateral facial pain or malar tenderness), or the presence of at least 1 major and 1 minor (frontal headache or fever [oral 38.0 C/100.4 F, tympanic 38.5 C/101.2 F, axillary 37.5 C/99.5 F]) symptom. Culture material was obtained by sinus puncture and the aspirated specimen sent to the central laboratory for Gram stain, quantitative culture, and susceptibility testing prior to initiation of antimicrobial therapy. Subjects with a history of chronic sinusitis, defined as greater than 4 weeks of continuous symptoms, were excluded.

3 Study Objectives: Overall: Evaluation Criteria: Statistical Methods: To evaluate the efficacy and safety of moxifloxacin 400 mg once daily (QD) for 5 days as compared with placebo in the treatment of acute bacterial sinusitis (ABS). Primary: The primary objective was the clinical response at the Test of Cure (TOC) visit in the Modified Intent-to- Treat (Modified ITT) population. Secondary: Secondary objectives included time to clinical improvement of sinusitis symptoms; subject-reported time to symptom improvement (Sino-Nasal Outcome Test-16 [SNOT-16] and Activity Impairment Assessment [AIA]); time to return to normal activities; clinical response during therapy and at long-term follow-up; microbiological response at the TOC visit and at long-term follow-up; and safety. Efficacy (Primary): The primary efficacy variable was clinical response at the TOC visit (Study Day +1 to +3, corresponding to 6 to 8 days after the start of therapy) in the Modified ITT population. Efficacy (Secondary): Secondary efficacy variables were time to clinical improvement of sinusitis symptoms; subject-reported time to symptom improvement (SNOT-16, AIA); time to return to normal activities; clinical response at the During Therapy visit and at long-term follow-up; and microbiological response at the TOC visit and at longterm follow-up. Safety Safety variables included the incidence of premature termination, adverse events, and clinical laboratory abnormalities. Pharmacokinetics Not applicable. All efficacy analyses were performed on data for the MITT, ITT, and per protocol populations. The primary efficacy population was the MITT population. Safety analyses were performed on data for the safety/itt population. A Cochran-Mantel-Haenszel test was performed to test the null hypothesis of no difference in the clinical cure rates between the moxifloxacin group and the placebo group. The test was to be 2 sided, using an level of In order to include all centers in the Cochran-Mantel-Haenszel test for the primary efficacy variable, clinical response, some small centers were combined for the purposes of analysis. Descriptive statistics were used for the secondary efficacy variables clinical response during therapy and at long-term follow-up, and time to improvement of symptoms. An additional secondary analysis was performed to compare the proportion of subjects with clinical cure who improved to the proportion of clinically cured subjects who obtained complete resolution. A minimally important difference (MID) was calculated for the Sino-Nasal Outcome Test-16 (SNOT-16) and Activity Impairment Assessment (AIA) scales. Comparison of the incidence rates of adverse events was done in a descriptive manner. Events were tabulated by type (according to the Medical Dictionary for Regulatory Activities [MedDRA] glossary) and frequency for all events and for those considered by the investigator to be drug-related. Laboratory data were analyzed using descriptive statistics and identification of values outside the normal range. Subjects with indeterminate (or missing) clinical evaluations at the TOC visit were included as clinical failures in the ITT and MITT analyses. For time-to-event analyses, subjects for whom the event had not occurred were considered censored at the time of their last evaluation. Number of Subjects: A total of 374 subjects were enrolled and randomized (251 in the moxifloxacin group and 123 in the placebo group). Of these 374 subjects, 118 were included in the MITT population (the primary analysis population). MITT subjects were defined as those subjects who received at least 1 dose of study drug and whose initial quantitative culture, obtained by sinus puncture, was positive for at least 1 of the following organisms: Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes, or Staphylococcus aureus (only if 10 4 colony forming units [CFU]/mL were present).

4 Results Summary Overall, most subjects in the MITT population were female (61.9%) and white (78.0%). The subjects ranged in age from 18 to 77 years, with a mean age of 38.4 years. The number of subjects included in each analysis population is summarized in Table 1. Table 1: Subjects Included in Each Analysis Population Analysis Population Moxifloxacin 400 mg Placebo Total Randomized Valid for ITT/Safety Valid for MITT Valid Per Protocol Abbreviations: ITT = intent-to-treat; MITT = modified intent-to-treat Subject Disposition and Baseline A total of 374 subjects enrolled at 37 study centers in the US received at least 1 dose of study medication and were included in the analysis of the safety/itt population. An additional subject was enrolled and randomized to study drug treatment at Center 75; however, midway through the study, the principal investigator developed a terminal illness. Numerous attempts to contact this site were unsuccessful, and this subject s data (including bacteriological, laboratory, and questionnaire data) were never entered in the CRF. Therefore, data for this subject are not in the clinical database and were not included in the analyses. Of the 251 subjects randomized to treatment with moxifloxacin, 222 (88.4%) subjects completed the study, and of the 123 subjects randomized to placebo, 101 (82.1%) subjects completed the study (P=0.0936). The leading cause of premature termination was insufficient therapeutic effect, with dropouts due to this reason occurring in the placebo group at nearly twice the rate as in the moxifloxacin group (16.3% versus 8.4%). Results Summary Efficacy Moxifloxacin 400 mg PO QD for 5 days failed to show statistically significant superiority over placebo in the treatment of subjects with ABS. Of the 73 MITT subjects treated with 400 mg moxifloxacin, 57 (78.1%) achieved clinical success (complete resolution, or improvement such that no further therapy with an antimicrobial agent, steroid, or irrigation was required) at the TOC visit compared with 30 of 45 (66.7%) MITT subjects who received placebo (P=0.189). The clinical success rate in the moxifloxacin group was close to the expected rate, while the clinical success rate in the placebo group exceeded the projection. The null hypothesis of treatment group equality could not be rejected, and the primary objective of the study was not achieved. Measuring clinical response at the Follow-up visit (Days +17 to +21) increased the difference in clinical success rate (combined clinical cure and continued clinical cure) to 16% (73.9% for moxifloxacin compared with 57.8% for placebo; P=0.067). Alleviation of symptoms was monitored using the SNOT 16 instrument, which showed that 5 days of treatment with moxifloxacin accelerated symptom relief as compared with placebo. The decrease in mean SNOT 16 scores reached a relative plateau between Day 3 and TOC for the placebo group, while mean scores in the moxifloxacin group continued to decrease. The proportion of subjects with signs and symptoms associated with ABS (cough, nasal congestion, postnasal drainage/discharge, purulent nasal drainage, anosmia, hyposmia, and ear pain/pressure/fullness) of moderate or severe intensity at TOC occurred at a rate at least 10% higher in the placebo group than in the moxifloxacin group. For all signs and symptoms, the proportion of subjects with intensity of none was higher in the moxifloxacin group. In general, concomitant medication use for symptomatic relief was lower in the moxifloxacin group as compared with the placebo group antibacterials for systemic use (used by 24.8% of moxifloxacin subjects and 36.1% of placebo subjects); nasal preparations (used by 11.4% of moxifloxacin subjects and 25.0% of placebo subjects); and corticosteroids for systemic use (used by 7.6% of moxifloxacin subjects and 17.9% of placebo subjects). Antibacterials and corticosteroids for systemic use were taken posttreatment by subjects who were treatment failures. The use of symptomatic relief medications decreased from baseline to TOC by 6.8% in the moxifloxacin group, while it increased by 15.6% in the placebo group. This difference was attributed to a higher rate of use in the placebo group of analgesics (P=0.023) and nasal preparations (P=0.062). The rate of premature discontinuation due to insufficient therapeutic effect was higher in the placebo group (22.2%) than in the moxifloxacin group (8.2%) (P=0.022). Although the 5-day moxifloxacin treatment did not meet the protocol-specified endpoint, there was substantial evidence of a positive treatment effect across a number of supportive analyses. Confounding factors, such as the nonstandardized use of concomitant medications for symptomatic relief, may have had an impact on its outcome and conclusions. Results Summary Pharmacokinetics Not applicable. Results Summary Safety The incidence of adverse events for the moxifloxacin and placebo groups is summarized in Table 2.

5 Table 2: Overview of Adverse Events (Subjects Valid for Safety) Moxifloxacin 400 mg (N=251) Placebo (N=123) n (%) n (%) At least 1 adverse event 96 (38.2%) 50 (40.7%) At least 1 drug-related adverse event 34 (13.5%) 6 (4.9%) At least 1 serious adverse event 1 (0.4%) 1 (0.8%) At least 1 drug-related serious adverse event 0 (0) 0 (0) Adverse event leading to discontinuation 3 (1.2%) 1 (0.8%) Death 0 (0) 0 (0) Note: The incidence rate is the number of subjects reporting any event with a start date during or after treatment / the number of subjects No deaths occurred during the study. Two subjects experienced nonfatal serious adverse events. Subject (moxifloxacin group) required hospitalization for severe pneumonia, and Subject (placebo group) required hospitalization for severe hypertension. Both serious adverse events occurred after study drug therapy was completed or stopped, and neither was considered by the investigator to be related to study drug therapy. Four subjects experienced adverse events leading to discontinuation of study drug treatment. Three of these subjects had events that were judged by the investigator to be related to study drug. Subject (placebo group) had drug-related abdominal pain, diarrhea, and a toxin-positive C difficile culture result. Subject (moxifloxacin group) experienced drug-related diarrhea. Subject (moxifloxacin group) experienced drug-related burning of the veins. Subject (moxifloxacin group) developed a tooth abscess that was unrelated to study drug. Among the clinical laboratory abnormalities, increases in liver transaminases and blood glucose were reported as treatment-emergent adverse events in both treatment groups. None of these laboratory adverse events led to discontinuation of study drug treatment. Moxifloxacin was well tolerated, and the observed safety profile was consistent with that seen in previous moxifloxacin studies evaluating the tablet formulation. Conclusion(s) In conclusion, the results of the present study did not demonstrate the statistically significant superiority of a 5-day regimen of moxifloxacin 400 mg QD compared with placebo in terms of the primary endpoint (clinical response at the TOC visit in the MITT population). Confounding factors, such as the nonstandardized use of concomitant medications for symptomatic relief, may have had an impact on its outcome and conclusions. There was, however, a clear trend in favor of moxifloxacin for most of the other efficacy variables, including accelerated symptom relief as evidenced by the SNOT-16 instrument, a better single symptom relief profile, lower usage of symptomatic relief medications, and a lower rate of premature discontinuation due to insufficient therapeutic effect. Moxifloxacin was well tolerated, and the observed safety profile was consistent with that seen in previous moxifloxacin studies evaluating the tablet formulation. Antimicrobial agents are recommended for certain patients with a diagnosis of ABS, and 7- and 10 day regimens of moxifloxacin are approved for the indication of ABS in Europe and the US, respectively. In addition, moxifloxacin has been shown to be clinically and bacteriologically efficacious in subjects who failed first-line treatment or who were at high risk for complications. Publication(s) Hadley JA, Mösges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope May;120(5): Updated: 08 Nov 2012

6 Appendix to Clinical Study Synopsis Product Identification Information Product Type Drug US Brand/Trade Name(s) Avelox [Oral formulation] Brand/Trade Name(s) ex-us Generic Name Main Product Company Code Other Company Code(s) Chemical Description Other Product Aliases Avelox Avalox Actira Octegra Izilox Havelox Megaxin Proflox Promira Moxifloxacin BAY n/a 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro- 6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline- 3-carboxylic acid hydrochloride. n/a Date of last Update/Change: 29 August 2012

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Period of study: 12 Nov 2002 to 08 Apr 2004 (first subject s first visit to last subject s last visit)

Period of study: 12 Nov 2002 to 08 Apr 2004 (first subject s first visit to last subject s last visit) Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency of Bayer's

More information

Srirupa Das, Associate Director, Medical Affairs, Tushar Fegade, Manager, Clinical Research Abbott Healthcare Private Limited, Mumbai.

Srirupa Das, Associate Director, Medical Affairs, Tushar Fegade, Manager, Clinical Research Abbott Healthcare Private Limited, Mumbai. Indian Medical Gazette JUNE 2015 225 Comparative A Randomized, Open Label, Prospective, Comparative Evaluating the Efficacy and Safety of Fixed Dose Combination of Cefpodoxime 200 Mg + Clavulanic Acid

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium tigecycline 50mg vial of powder for intravenous infusion (Tygacil ) (277/06) Wyeth 9 June 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the

More information

moxifloxacin intravenous, 400mg/250mL, solution for infusion (Avelox ) SMC No. (650/10) Bayer Schering

moxifloxacin intravenous, 400mg/250mL, solution for infusion (Avelox ) SMC No. (650/10) Bayer Schering moxifloxacin intravenous, 400mg/250mL, solution for infusion (Avelox ) SMC No. (650/10) Bayer Schering 05 November 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above

More information

Lefamulin Evaluation Against Pneumonia (LEAP 1) Phase 3 Topline Results. September 18, 2017

Lefamulin Evaluation Against Pneumonia (LEAP 1) Phase 3 Topline Results. September 18, 2017 Lefamulin Evaluation Against Pneumonia (LEAP 1) Phase 3 Topline Results September 18, 2017 Safe Harbor and Disclaimer Any statements in this presentation about future expectations, plans and prospects

More information

Synopsis. Takeda Pharmaceutical Company Limited Name of the finished product UNISIA Combination Tablets LD, UNISIA Combination Tablets

Synopsis. Takeda Pharmaceutical Company Limited Name of the finished product UNISIA Combination Tablets LD, UNISIA Combination Tablets Synopsis Name of the sponsor Takeda Pharmaceutical Company Limited Name of the finished product UNISIA Combination Tablets LD, UNISIA Combination Tablets Name of active ingredient Title of the study Study

More information

Delayed Prescribing for Minor Infections Resource Pack for Prescribers

Delayed Prescribing for Minor Infections Resource Pack for Prescribers Delayed Prescribing for Minor Infections Resource Pack for Prescribers Background: Antibiotic resistance is an alarming threat to modern healthcare, and infectious illness remains a major global threat

More information

Suitability of Antibiotic Treatment for CAP (CAPTIME) The duration of antibiotic treatment in community acquired pneumonia (CAP)

Suitability of Antibiotic Treatment for CAP (CAPTIME) The duration of antibiotic treatment in community acquired pneumonia (CAP) STUDY PROTOCOL Suitability of Antibiotic Treatment for CAP (CAPTIME) Purpose The duration of antibiotic treatment in community acquired pneumonia (CAP) lasts about 9 10 days, and is determined empirically.

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: (Nuzyra) Reference Number: CP.PMN.## Effective Date: 11.20.18 Last Review Date: 02.19 Line of Business: Commercial, TBD HIM*, Medicaid Coding Implications Revision Log See Important Reminder

More information

Moxifloxacin (as hydrochloride) 400 mg Tablets WHOPAR part 6 November 2017 (Hetero Labs Limited), TB 315

Moxifloxacin (as hydrochloride) 400 mg Tablets WHOPAR part 6 November 2017 (Hetero Labs Limited), TB 315 This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1

More information

Clinical Policy: Linezolid (Zyvox) Reference Number: CP.PMN.27 Effective Date: Last Review Date: Line of Business: HIM*, Medicaid

Clinical Policy: Linezolid (Zyvox) Reference Number: CP.PMN.27 Effective Date: Last Review Date: Line of Business: HIM*, Medicaid Clinical Policy: (Zyvox) Reference Number: CP.PMN.27 Effective Date: 09.01.06 Last Review Date: 02.19 Line of Business: HIM*, Medicaid Coding Implications Revision Log See Important Reminder at the end

More information

Université catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium. Bayer Santé SAS, Loos, France

Université catholique de Louvain, Louvain Drug Research Institute, Brussels, Belgium. Bayer Santé SAS, Loos, France Communicating Comprehensive Safety Data Gained from Clinical Trials to the Scientific Community: Opportunities and Difficulties from an Example with Moxifloxacin P.M. Tulkens, 1 P. Arvis, 2 F. Kruesmann,

More information

DOSAGE FORMS AND STRENGTHS Otic Suspension: Each OTIPRIO vial contains 1 ml of 6% (60 mg/ml) ciprofloxacin otic suspension. (3)

DOSAGE FORMS AND STRENGTHS Otic Suspension: Each OTIPRIO vial contains 1 ml of 6% (60 mg/ml) ciprofloxacin otic suspension. (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTIPRIO safely and effectively. See full prescribing information for OTIPRIO. OTIPRIO (ciprofloxacin

More information

Pharmacoeconomic analysis of selected antibiotics in lower respiratory tract infection Quenzer R W, Pettit K G, Arnold R J, Kaniecki D J

Pharmacoeconomic analysis of selected antibiotics in lower respiratory tract infection Quenzer R W, Pettit K G, Arnold R J, Kaniecki D J Pharmacoeconomic analysis of selected antibiotics in lower respiratory tract infection Quenzer R W, Pettit K G, Arnold R J, Kaniecki D J Record Status This is a critical abstract of an economic evaluation

More information

Prescribing Guidelines for Outpatient Antimicrobials in Otherwise Healthy Children

Prescribing Guidelines for Outpatient Antimicrobials in Otherwise Healthy Children Prescribing Guidelines for Outpatient Antimicrobials in Otherwise Healthy Children Prescribing Antimicrobials for Common Illnesses When treating common illnesses such as ear infections and strep throat,

More information

Let me clear my throat: empiric antibiotics in

Let me clear my throat: empiric antibiotics in Let me clear my throat: empiric antibiotics in respiratory tract infections Alexander John Langley, MD MS MPH Goals of this talk Overuse of antibiotics is a major issue, as a result many specialist medical

More information

Phase III Clinical Trial of Moxifloxacin Hydrochloride in the Treatment of Acute Exacerbations of Chronic Bronchitis in Comparison with Azithromycin

Phase III Clinical Trial of Moxifloxacin Hydrochloride in the Treatment of Acute Exacerbations of Chronic Bronchitis in Comparison with Azithromycin ORIGINAL ARTICLE JIACM 2002; 3(4): 360-6 Phase III Clinical Trial of Moxifloxacin Hydrochloride in the Treatment of Acute Exacerbations of Chronic Bronchitis in Comparison with Azithromycin SH Talib*,

More information

Clinical Policy: Linezolid (Zyvox) Reference Number: CP.PMN.27 Effective Date: Last Review Date: Line of Business: Oregon Health Plan

Clinical Policy: Linezolid (Zyvox) Reference Number: CP.PMN.27 Effective Date: Last Review Date: Line of Business: Oregon Health Plan Clinical Policy: (Zyvox) Reference Number: CP.PMN.27 Effective Date: 07.01.18 Last Review Date: 05.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium daptomycin 350mg powder for concentrate for solution for infusion (Cubicin ) Chiron Corporation Limited No. (248/06) 10 March 2006 The Scottish Medicines Consortium (SMC)

More information

Clinical Policy: Clindamycin (Cleocin) Reference Number: CP.HNMC.08 Effective Date: Last Review Date: Line of Business: Medicaid - HNMC

Clinical Policy: Clindamycin (Cleocin) Reference Number: CP.HNMC.08 Effective Date: Last Review Date: Line of Business: Medicaid - HNMC Clinical Policy: (Cleocin) Reference Number: CP.HNMC.08 Effective Date: 07.01.17 Last Review Date: 02.18 Line of Business: Medicaid - HNMC Revision Log See Important Reminder at the end of this policy

More information

Class Update with New Drug Evaluation: Ototopical Antibiotics

Class Update with New Drug Evaluation: Ototopical Antibiotics Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119

More information

Inappropriate Use of Antibiotics and Clostridium difficile Infection. Jocelyn Srigley, MD, FRCPC November 1, 2012

Inappropriate Use of Antibiotics and Clostridium difficile Infection. Jocelyn Srigley, MD, FRCPC November 1, 2012 Inappropriate Use of Antibiotics and Clostridium difficile Infection Jocelyn Srigley, MD, FRCPC November 1, 2012 Financial Disclosures } No conflicts of interest } The study was supported by a Hamilton

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/CVMP/627/01-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE DEMONSTRATION OF EFFICACY

More information

ECHO: Management of URIs. Charles Krasner, M.D. Sierra NV Veterans Affairs Hospital University of NV, Reno School of Medicine October 16, 2018

ECHO: Management of URIs. Charles Krasner, M.D. Sierra NV Veterans Affairs Hospital University of NV, Reno School of Medicine October 16, 2018 ECHO: Management of URIs Charles Krasner, M.D. Sierra NV Veterans Affairs Hospital University of NV, Reno School of Medicine October 16, 2018 Infectious causes of URIs change over time Most ARIs are viral

More information

COLLEGE OF VETERINARY MEDICINE

COLLEGE OF VETERINARY MEDICINE Title: A randomized, masked, placebo controlled field study to determine efficacy and safety of Paccal Vet in dogs with non resectable (or unresected) mammary carcinoma of stage III-V 1. Why is the study

More information

Critical Appraisal Topic. Antibiotic Duration in Acute Otitis Media in Children. Carissa Schatz, BSN, RN, FNP-s. University of Mary

Critical Appraisal Topic. Antibiotic Duration in Acute Otitis Media in Children. Carissa Schatz, BSN, RN, FNP-s. University of Mary Running head: ANTIBIOTIC DURATION IN AOM 1 Critical Appraisal Topic Antibiotic Duration in Acute Otitis Media in Children Carissa Schatz, BSN, RN, FNP-s University of Mary 2 Evidence-Based Practice: Critical

More information

Volume 2; Number 16 October 2008

Volume 2; Number 16 October 2008 Volume 2; Number 16 October 2008 What s new this month NHS Lincolnshire have launched a public information campaign designed to raise public awareness of the risks associated with the inappropriate use

More information

CLINICAL USE OF BETA-LACTAMS

CLINICAL USE OF BETA-LACTAMS CLINICAL USE OF BETA-LACTAMS Douglas Black, Pharm.D. Associate Professor School of Pharmacy University of Washington dblack@u.washington.edu WHY IS INFECTIOUS DISEASE PHARMACOTHERAPY SO CONFUSING? Microbial

More information

Drug Class Literature Scan: Otic Antibiotics

Drug Class Literature Scan: Otic Antibiotics Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119

More information

Rational use of antibiotic in upper respiratory tract infection (URI) and community acquired pneumonia รศ.จามร ธ รตก ลพ ศาล 23 พฤษภาคม 2550

Rational use of antibiotic in upper respiratory tract infection (URI) and community acquired pneumonia รศ.จามร ธ รตก ลพ ศาล 23 พฤษภาคม 2550 Rational use of antibiotic in upper respiratory tract infection (URI) and community acquired pneumonia รศ.จามร ธ รตก ลพ ศาล 23 พฤษภาคม 2550 Sinusitis Upper respiratory tract infections (URI) Common cold

More information

Appropriate Management of Common Pediatric Infections. Blaise L. Congeni M.D. Akron Children s Hospital Division of Pediatric Infectious Diseases

Appropriate Management of Common Pediatric Infections. Blaise L. Congeni M.D. Akron Children s Hospital Division of Pediatric Infectious Diseases Appropriate Management of Common Pediatric Infections Blaise L. Congeni M.D. Akron Children s Hospital Division of Pediatric Infectious Diseases It s all about the microorganism The common pathogens Viruses

More information

Bacterial skin and soft tissues infections (SSTI) are one of the most common 1. infections among different age groups

Bacterial skin and soft tissues infections (SSTI) are one of the most common 1. infections among different age groups Bacterial skin and soft tissues infections (SSTI) are one of the most common 1 infections among different age groups Gram-positive bacteria are the most frequently isolated pathogens from SSTI, with a

More information

PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS

PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE VERTEBRATE ANIMALS Federal animal welfare regulations require that the Institutional Animal Care and Use Committee (IACUC) must review and approve all activities

More information

Antibiotics & treatment of Acute Bcterial Sinusitis. Walid Reda Product Manager. Do your antimicrobial options meet your needs?

Antibiotics & treatment of Acute Bcterial Sinusitis. Walid Reda Product Manager. Do your antimicrobial options meet your needs? Antibiotics & treatment of Acute Bcterial Sinusitis Walid Reda Product Manager Do your antimicrobial options meet your needs? Antimicrobial Effects: What s involved? Effect in Humans: Serum concentration

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Reference Number: CP.HNMC.04 Effective Date: 07.01.17 Last Review Date: 02.18 Line of Business: Medicaid - HNMC Revision Log See Important Reminder at the end of this policy for important

More information

Safety of an Out-Patient Intravenous Antibiotics Programme

Safety of an Out-Patient Intravenous Antibiotics Programme Safety of an Out-Patient Intravenous Antibiotics Programme Chan VL, Tang ESK, Leung WS, Wong L, Cheung PS, Chu CM Department of Medicine & Geriatrics United Christian Hospital Outpatient Parental Antimicrobial

More information

Volume. December Infection. Notes. length of. cases as 90% 1 week. tonsillitis. First Line. sore throat / daily for 5 days. quinsy >4000.

Volume. December Infection. Notes. length of. cases as 90% 1 week. tonsillitis. First Line. sore throat / daily for 5 days. quinsy >4000. Volume 8; Number 22 LINCOLNSHIRE GUIDELINES FOR THE TREATMENT OF COMMONLYY OCCURRING INFECTIONS IN PRIMARY CARE: WINTER 2014/15 In this issue of the PACE Bulletin we present an update of our Guidelines

More information

Paratek Announces FDA Approval of NUZYRA (Omadacycline)

Paratek Announces FDA Approval of NUZYRA (Omadacycline) Paratek Announces FDA Approval of NUZYRA (Omadacycline) Modernized Tetracycline for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI)

More information

4/3/2017 CLINICAL PEARLS: UPDATES IN THE MANAGEMENT OF NOSOCOMIAL PNEUMONIA DISCLOSURE LEARNING OBJECTIVES

4/3/2017 CLINICAL PEARLS: UPDATES IN THE MANAGEMENT OF NOSOCOMIAL PNEUMONIA DISCLOSURE LEARNING OBJECTIVES CLINICAL PEARLS: UPDATES IN THE MANAGEMENT OF NOSOCOMIAL PNEUMONIA BILLIE BARTEL, PHARMD, BCCCP APRIL 7 TH, 2017 DISCLOSURE I have had no financial relationship over the past 12 months with any commercial

More information

Antibacterial Resistance: Research Efforts. Henry F. Chambers, MD Professor of Medicine University of California San Francisco

Antibacterial Resistance: Research Efforts. Henry F. Chambers, MD Professor of Medicine University of California San Francisco Antibacterial Resistance: Research Efforts Henry F. Chambers, MD Professor of Medicine University of California San Francisco Resistance Resistance Dose-Response Curve Antibiotic Exposure Anti-Resistance

More information

AZITHROMYCIN, DOXYCYCLINE, AND FLUOROQUINOLONES

AZITHROMYCIN, DOXYCYCLINE, AND FLUOROQUINOLONES AZITHROMYCIN, DOXYCYCLINE, AND FLUOROQUINOLONES Update in Medicine and Primary Care Whitney R. Buckel, PharmD, BCPS-AQ ID System Antimicrobial Stewardship Pharmacist Manager OBJECTIVES 1. List three antibiotics

More information

Randomized Controlled Trial on Adjunctive Lavage for Severe Peritoneal Dialysis- Related Peritonitis

Randomized Controlled Trial on Adjunctive Lavage for Severe Peritoneal Dialysis- Related Peritonitis Randomized Controlled Trial on Adjunctive Lavage for Severe Peritoneal Dialysis- Related Peritonitis Steve SM Wong Alice Ho Miu Ling Nethersole Hospital Background PD peritonitis is a major cause of PD

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1.

SUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephacare flavour 50 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active

More information

Canadian Nosocomial Infection Surveillance Program 2018 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING HIP AND KNEE ARTHROPLASTY

Canadian Nosocomial Infection Surveillance Program 2018 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING HIP AND KNEE ARTHROPLASTY Canadian Nosocomial Infection Surveillance Program 2018 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING HIP AND KNEE ARTHROPLASTY FINAL Working Group: Dominik Mertz (Chair) Elizabeth Henderson, Johan

More information

Treatment Duration for Uncomplicated Community-Acquired Pneumonia: The Evidence in Support of 5 Days

Treatment Duration for Uncomplicated Community-Acquired Pneumonia: The Evidence in Support of 5 Days Treatment Duration for Uncomplicated Community-Acquired Pneumonia: The Evidence in Support of 5 Days Executive Summary National consensus guidelines created jointly by the Infectious Diseases Society of

More information

GUIDELINES FOR THE MANAGEMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS

GUIDELINES FOR THE MANAGEMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS Version 3.1 GUIDELINES FOR THE MANAGEMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS Date ratified June 2008 Updated March 2009 Review date June 2010 Ratified by Authors Consultation Evidence base Changes

More information

CME/CE QUIZ CME/CE QUESTIONS. a) 20% b) 22% c) 34% d) 35% b) Susceptible and resistant strains of typical respiratory

CME/CE QUIZ CME/CE QUESTIONS. a) 20% b) 22% c) 34% d) 35% b) Susceptible and resistant strains of typical respiratory CME/CE QUIZ CME/CE QUESTIONS Continuing Medical Education Accreditation This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for

More information

Cephalosporins, Quinolones and Co-amoxiclav Prescribing Audit

Cephalosporins, Quinolones and Co-amoxiclav Prescribing Audit Cephalosporins, Quinolones and Co-amoxiclav Prescribing Audit Executive Summary Background Antibiotic resistance poses a significant threat to public health, as antibiotics underpin routine medical practice.

More information

JMSCR Vol 05 Issue 03 Page March 2017

JMSCR Vol 05 Issue 03 Page March 2017 www.jmscr.igmpublication.org Impact Factor 5.84 Index Copernicus Value: 83.27 ISSN (e)-2347-176x ISSN (p) 2455-0450 DOI: https://dx.doi.org/10.18535/jmscr/v5i3.219 Comparative Study of Adverse Effect of

More information

Treating Rosacea in the Era of Bacterial Resistance. This presentation is sponsored by Galderma Laboratories, L.P.

Treating Rosacea in the Era of Bacterial Resistance. This presentation is sponsored by Galderma Laboratories, L.P. Treating Rosacea in the Era of Bacterial Resistance This presentation is sponsored by Galderma Laboratories, L.P. Lecture Discuss rosacea as an inflammatory condition Assess the psychosocial impact of

More information

A study on the management of acute respiratory tract infection in adults

A study on the management of acute respiratory tract infection in adults Aug. 2014 THE JAPANESE JOURNAL OF ANTIBIOTICS 67 4 223 9 A study on the management of acute respiratory tract infection in adults YOSHIHIRO YAMAMOTO 1, MITSUHIDE OHMICHI 2, AKIRA WATANABE 3, YOSHITO NIKI

More information

SECTION 3A. Section 3A Criteria for Optional Special Authorization of Select Drug Products

SECTION 3A. Section 3A Criteria for Optional Special Authorization of Select Drug Products SECTION 3A Criteria for Optional Special Authorization of Select Drug Products Section 3A Criteria for Optional Special Authorization of Select Drug Products CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION

More information

S aureus infections: outpatient treatment. Dirk Vogelaers Dept of Infectious Diseases University Hospital Gent Belgium

S aureus infections: outpatient treatment. Dirk Vogelaers Dept of Infectious Diseases University Hospital Gent Belgium S aureus infections: outpatient treatment Dirk Vogelaers Dept of Infectious Diseases University Hospital Gent Belgium Intern Med J. 2005 Feb;36(2):142-3 Intern Med J. 2005 Feb;36(2):142-3 Treatment of

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RONAXAN 20mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance : Doxycycline (as doxycycline

More information

amoxycillin/clavulanate vs placebo in the prevention of infection after animal

amoxycillin/clavulanate vs placebo in the prevention of infection after animal Archives of Emergency Medicine, 1989, 6, 251-256 A comparative double blind study of amoxycillin/clavulanate vs placebo in the prevention of infection after animal bites P. H. BRAKENBURY & C. MUWANGA Accident

More information

Treatment of Surgical Site Infection Meeting Quality Statement 6. Prof Peter Wilson University College London Hospitals

Treatment of Surgical Site Infection Meeting Quality Statement 6. Prof Peter Wilson University College London Hospitals Treatment of Surgical Site Infection Meeting Quality Statement 6 Prof Peter Wilson University College London Hospitals TEG Quality Standard 6 Treatment and effective antibiotic prescribing: People with

More information

Antimicrobial Update Stewardship in Primary Care. Clare Colligan Antimicrobial Pharmacist NHS Forth Valley

Antimicrobial Update Stewardship in Primary Care. Clare Colligan Antimicrobial Pharmacist NHS Forth Valley Antimicrobial Update Stewardship in Primary Care Clare Colligan Antimicrobial Pharmacist NHS Forth Valley Setting the Scene! Consequences of Antibiotic Use? Resistance For an individual patient with

More information

Newsflash: Hospital Medicine JOHN C. CHRISTENSEN, MD FACP AMERICAN COLLEGE OF PHYSICIANS, UTAH CHAPTER SCIENTIFIC MEETING FEBRUARY 10, 2017

Newsflash: Hospital Medicine JOHN C. CHRISTENSEN, MD FACP AMERICAN COLLEGE OF PHYSICIANS, UTAH CHAPTER SCIENTIFIC MEETING FEBRUARY 10, 2017 Newsflash: Hospital Medicine JOHN C. CHRISTENSEN, MD FACP AMERICAN COLLEGE OF PHYSICIANS, UTAH CHAPTER SCIENTIFIC MEETING FEBRUARY 10, 2017 Newsflash: Fluoroquinolones Newsflash: Fluoroquinolones Don t

More information

CHAPTER:1 THE RATIONAL USE OF ANTIBIOTICS. BY Mrs. K.SHAILAJA., M. PHARM., LECTURER DEPT OF PHARMACY PRACTICE, SRM COLLEGE OF PHARMACY

CHAPTER:1 THE RATIONAL USE OF ANTIBIOTICS. BY Mrs. K.SHAILAJA., M. PHARM., LECTURER DEPT OF PHARMACY PRACTICE, SRM COLLEGE OF PHARMACY CHAPTER:1 THE RATIONAL USE OF ANTIBIOTICS BY Mrs. K.SHAILAJA., M. PHARM., LECTURER DEPT OF PHARMACY PRACTICE, SRM COLLEGE OF PHARMACY Antibiotics One of the most commonly used group of drugs In USA 23

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates

More information

Tolerance and safety of enalapril

Tolerance and safety of enalapril Br. J. clin. Pharmac. (1984), 18, 249S-253S Tolerance and safety of enalapril W. McFATE SMITH, R. 0. DAVIES, M. A. GABRIEL, D. M. KRAMSCH, F. MONCLOA, JANET E. RUSH & J. F. WALKER Merck Sharp & Dohme Research

More information

Interventions for children with ear discharge occurring at least two weeks following grommet(ventilation tube) insertion(review)

Interventions for children with ear discharge occurring at least two weeks following grommet(ventilation tube) insertion(review) Cochrane Database of Systematic Reviews Interventions for children with ear discharge occurring at least two weeks following grommet(ventilation tube) insertion(review) Venekamp RP, Javed F, van Dongen

More information

ISMP Canada HYDROmorphone Knowledge Assessment Survey

ISMP Canada HYDROmorphone Knowledge Assessment Survey ISMP Canada HYDROmorphone Knowledge Assessment Survey Knowledge Assessment Questions 1. In an equipotent dose, HYDROmorphone is more potent than morphine. True False Unsure 2. HYDROmorphone can be given

More information

PDF hosted at the Radboud Repository of the Radboud University Nijmegen

PDF hosted at the Radboud Repository of the Radboud University Nijmegen PDF hosted at the Radboud Repository of the Radboud University Nijmegen The following full text is a publisher's version. For additional information about this publication click this link. http://hdl.handle.net/266/9665

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PL, PT, RO, SI,

More information

Submission for Reclassification

Submission for Reclassification Submission for Reclassification Fucithalmic (Fusidic Acid 1% Eye Drops) From Prescription Medicine to Restricted Medicine (Pharmacist Only Medicine) CSL Biotherapies (NZ) Limited 666 Great South Road Penrose

More information

Clinical trials conducted in subjects with naturally

Clinical trials conducted in subjects with naturally Review J Vet Intern Med 2013 Evidence-Based Medicine: The Design and Interpretation of Noninferiority Clinical Trials in Veterinary Medicine K.J. Freise, T.-L. Lin, T.M. Fan, V. Recta, and T.P. Clark Noninferiority

More information

Guideline on the conduct of efficacy studies for intramammary products for use in cattle

Guideline on the conduct of efficacy studies for intramammary products for use in cattle 1 2 3 18 October 2013 EMEA/CVMP/EWP/141272/2011 Committee for Medicinal products for Veterinary Use (CVMP) 4 5 6 Guideline on the conduct of efficacy studies for intramammary products for use in cattle

More information

THE VETERINARIAN'S CHOICE. Compendium clinical Trials. Introducing new MILPRO. from Virbac. Go pro. Go MILPRO..

THE VETERINARIAN'S CHOICE. Compendium clinical Trials. Introducing new MILPRO. from Virbac. Go pro. Go MILPRO.. THE VETERINARIAN'S CHOICE. Introducing new MILPRO from Virbac. Compendium clinical Trials Go pro. Go MILPRO.. milbemycin/praziquantel Content INTRODUCTION 05 I. EFFICACY STUDIES IN CATS 06 I.I. Efficacy

More information

EPAR type II variation for Metacam

EPAR type II variation for Metacam 23 June 2011 EMA/674662/2011 International Non-proprietary Name: Meloxicam Procedure No. EMEA/V/C/033/II/084 EU/2/97/004/026, 33-34 Scope: Type II Addition of indication for cats Page 1/6 Table of contents

More information

Community Acquired Pneumonia: An Update on Guidelines

Community Acquired Pneumonia: An Update on Guidelines Community Acquired Pneumonia: An Update on Guidelines Claudia Summa, BScPhm Pharmacy Resident September 12, 2006 Objectives To give a brief description of the pathophysiology of community acquired pneumonia

More information

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see:

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see: Antibiotic treatment and monitoring for suspected or confirmed early-onset neonatal infection bring together everything NICE says on a topic in an interactive flowchart. are interactive and designed to

More information

Simplicef is Used to Treat Animals with Skin Infections

Simplicef is Used to Treat Animals with Skin Infections Simplicef is Used to Treat Animals with Skin Infections PRODUCT INFO Simplicef tablets are a semi-synthetic cephalosporin antibiotic cefpodoxime proxetil used to cure infections caused by the susceptible

More information

Pneumonia Antibiotic Guidance for Adults PAGL Inclusion Approved at January 2017 PGC

Pneumonia Antibiotic Guidance for Adults PAGL Inclusion Approved at January 2017 PGC Pneumonia Antibiotic Guidance for Adults PAGL Inclusion Approved at January 2017 PGC APPROVED BY: Policy and Guidelines Committee TRUST REFERENCE: B9/2009 AWP Ref: AWP61 Date (approved): July 2008 REVIEW

More information

3/23/2017. Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc. Kathryn G. Smith: Nothing to disclose

3/23/2017. Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc. Kathryn G. Smith: Nothing to disclose Kathryn G. Smith, PharmD PGY1 Pharmacy Resident Via Christi Hospitals Wichita, Inc Kathryn G. Smith: Nothing to disclose Describe the new updates and rationale for them Relay safety concerns with use of

More information

Public Assessment Report Paediatric data. EXOCIN (OCUFLOX) Ofloxacin. Marketing Autorisation Holder: Allergan

Public Assessment Report Paediatric data. EXOCIN (OCUFLOX) Ofloxacin. Marketing Autorisation Holder: Allergan Public Assessment Report Paediatric data EXOCIN (OCUFLOX) Ofloxacin Marketing Autorisation Holder: Allergan Rapporteur: Co-Rapporteur: Currently approved indication(s): Pharmaceutical form(s) and strengths

More information

Combination vs Monotherapy for Gram Negative Septic Shock

Combination vs Monotherapy for Gram Negative Septic Shock Combination vs Monotherapy for Gram Negative Septic Shock Critical Care Canada Forum November 8, 2018 Michael Klompas MD, MPH, FIDSA, FSHEA Professor, Harvard Medical School Hospital Epidemiologist, Brigham

More information

CLINICAL PROTOCOL FOR COMMUNITY ACQUIRED PNEUMONIA. SCOPE: Western Australia. CORB score equal or above 1. All criteria must be met:

CLINICAL PROTOCOL FOR COMMUNITY ACQUIRED PNEUMONIA. SCOPE: Western Australia. CORB score equal or above 1. All criteria must be met: CLINICAL PROTOCOL F COMMUNITY ACQUIRED PNEUMONIA SCOPE: Western Australia All criteria must be met: Inclusion Criteria Exclusion Criteria CB score equal or above 1. Mild/moderate pneumonia confirmed by

More information

Developing Well-Differentiated Antibiotics. June 2017 Mark Hahn Chief Financial Officer

Developing Well-Differentiated Antibiotics. June 2017 Mark Hahn Chief Financial Officer Developing Well-Differentiated Antibiotics June 2017 Mark Hahn Chief Financial Officer Forward Looking Statements This presentation contains forward-looking statements regarding future events. These statements

More information

2017 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING TOTAL HIP AND KNEE ARTHROPLASTY

2017 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING TOTAL HIP AND KNEE ARTHROPLASTY Canadian Nosocomial Infection Surveillance Program 2017 SURVEILLANCE OF SURGICAL SITES INFECTIONS FOLLOWING TOTAL HIP AND KNEE ARTHROPLASTY FINAL Working Group: E. Henderson, M. John, I. Davis, S. Dunford,

More information

For analyst certification and disclosures please see page 7

For analyst certification and disclosures please see page 7 Physician Survey Survey of Healthcare Professionals on Community-Acquired Bacterial Pneumonia We conducted a survey on prescribing habits for community-acquired bacterial pneumonia (CABP) in order to better

More information

Managing winter illnesses without antibiotics

Managing winter illnesses without antibiotics CLINICAL AUDIT Managing winter illnesses without antibiotics Valid to June 2023 bpac nz better medicin e Background Over the winter months, thousands of people across New Zealand will present to primary

More information

Objective 1/20/2016. Expanding Antimicrobial Stewardship into the Outpatient Setting. Disclosure Statement of Financial Interest

Objective 1/20/2016. Expanding Antimicrobial Stewardship into the Outpatient Setting. Disclosure Statement of Financial Interest Expanding Antimicrobial Stewardship into the Outpatient Setting Michael E. Klepser, Pharm.D., FCCP Professor Pharmacy Practice Ferris State University College of Pharmacy Disclosure Statement of Financial

More information

Is Robenacoxib Superior to Meloxicam in Improving Patient Comfort in Dog Diagnosed With a Degenerative Joint Process?

Is Robenacoxib Superior to Meloxicam in Improving Patient Comfort in Dog Diagnosed With a Degenerative Joint Process? Is Robenacoxib Superior to Meloxicam in Improving Patient Comfort in Dog Diagnosed With a Degenerative Joint Process? A Knowledge Summary by Adam Swallow BVSc MRCVS 1* 1 University of Bristol * Corresponding

More information

Comparison of cefpodoxime proxetil with cefaclor in the treatment of sinusitis

Comparison of cefpodoxime proxetil with cefaclor in the treatment of sinusitis Journal of Antimicrobial Chemotherapy () 6, Suppl. E, 87- Comparison of cefpodoxime proxetil with cefaclor in the treatment of sinusitis P. Gehanno", J. Depondt", B. Barry", M. Simonet* and H. Dewever"

More information

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICATION PATIENT MEDICATION INFORMATION. Moxifloxacin tablets (as moxifloxacin hydrochloride)

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICATION PATIENT MEDICATION INFORMATION. Moxifloxacin tablets (as moxifloxacin hydrochloride) READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICATION PATIENT MEDICATION INFORMATION Pr Sandoz Moxifloxacin Moxifloxacin tablets (as moxifloxacin hydrochloride) Read this carefully before you start taking

More information

Antimicrobial Stewardship

Antimicrobial Stewardship Antimicrobial Stewardship Report: 11 th August 2016 Issue: As part of ensuring compliance with the National Safety and Quality Health Service Standards (NSQHS), Yea & District Memorial Hospital is required

More information

Is amoxicillin good for viral infections

Is amoxicillin good for viral infections Is amoxicillin good for viral infections 19-6-2017 Is Amoxicillin Good For Throat Infection. They will not help sore throats caused by allergies or viral infections such as colds amoxicillin is. Reviews

More information

ACUTE EXACERBATIONS of COPD (AE-COPD) : The Belgian perspective

ACUTE EXACERBATIONS of COPD (AE-COPD) : The Belgian perspective ACUTE EXACERBATIONS of COPD (AE-COPD) : The Belgian perspective Antwerpen 8 november 2002 Yvan Valcke MD PhD AZ Maria Middelares Sint-Niklaas ACUTE EXACERBATIONS of COPD (AE-COPD) Treatment of AECB Role

More information

Update on Fluoroquinolones. Charles Krasner, M.D. June 16, 2016 Antibiotic Stewardship Program -ECHO

Update on Fluoroquinolones. Charles Krasner, M.D. June 16, 2016 Antibiotic Stewardship Program -ECHO Update on Fluoroquinolones Charles Krasner, M.D. June 16, 2016 Antibiotic Stewardship Program -ECHO Potential fluoroquinolone side-effects Increased risk, greater than with most other antibiotics, for

More information

Antibiotic stewardship in long term care

Antibiotic stewardship in long term care Antibiotic stewardship in long term care Shira Doron, MD Associate Professor of Medicine Division of Geographic Medicine and Infectious Diseases Tufts Medical Center Boston, MA Consultant to Massachusetts

More information

4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals

4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals 1.B1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXYCOL Soluble Powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Amoxicillin trihydrate 640.0

More information

Original Articles. Introduction C. A. DEABATE*, C.P.MATHEW {,J.H.WARNER { A. HEYD { AND D. CHURCH {

Original Articles. Introduction C. A. DEABATE*, C.P.MATHEW {,J.H.WARNER { A. HEYD { AND D. CHURCH { RESPIRATORY MEDICINE (2000) 94, 1029 1037 doi:10.1053/rmed.2000.0927, available online at http://www.idealibrary.com on Original Articles The safety and efficacy of short course (5-day) moxifloxacin vs.

More information

Author - Dr. Josie Traub-Dargatz

Author - Dr. Josie Traub-Dargatz Author - Dr. Josie Traub-Dargatz Dr. Josie Traub-Dargatz is a professor of equine medicine at Colorado State University (CSU) College of Veterinary Medicine and Biomedical Sciences. She began her veterinary

More information

American Association of Feline Practitioners American Animal Hospital Association

American Association of Feline Practitioners American Animal Hospital Association American Association of Feline Practitioners American Animal Hospital Association Basic Guidelines of Judicious Therapeutic Use of Antimicrobials August 1, 2006 Introduction The Basic Guidelines to Judicious

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amfipen LA 100 mg/ml suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains:

More information

Protocol for exit-site care and treatment of exit-site infections in peritoneal dialysis CONTROLLED DOCUMENT

Protocol for exit-site care and treatment of exit-site infections in peritoneal dialysis CONTROLLED DOCUMENT CONTROLLED DOCUMENT Protocol for exit-site care and treatment of exit-site infections in peritoneal dialysis CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Guideline Clinical The purpose

More information

Healthcare-associated Infections Annual Report December 2018

Healthcare-associated Infections Annual Report December 2018 December 2018 Healthcare-associated Infections Annual Report 2011-2017 TABLE OF CONTENTS INTRODUCTION... 1 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTIONS... 2 MRSA SURVEILLANCE... 3 CLOSTRIDIUM

More information