STANDARD OPERATING PROCEDURE: TRUST ANTIBIOTIC TREATMENT SOP SOP NO: TW10/136 SOP 1 VERSION NO: VERSION 6.1 (JANUARY 2013) APPROVING COMMITTEE: INFECTION PREVENTION AND CONTROL COMMITTEE DATE THIS VERSION APPROVED: JULY 2012 RATIFYING COMMITTEE: PARC (Policy Approval and Ratification Committee) DATE THIS VERSION RATIFIED: June 2013 AMENDMENTS MADE TO DOCUMENT: AUTHOR(S) (JOB TITLE) DIVISION/DIRECTORATE TRUST WIDE SOP (YES/NO) LINKS TO OTHER POLICIES, SOP S, STRATEGIES ETC: Complicated UTI/pyelonephritis and catheter associated UTI treatment guidelines, recommended co-amoxiclav + gentamicin instead of tazocin. CONSULTANT MICROBIOLOGIST MEDICINE YES Antimicrobial Prescribing Policy Community Parenteral Antibiotic Therapy Guidelines and Formulary Clostridium difficile Infection (CDI) Treatment Guidelines Antibiotic Guidelines for Surgical Patients Infection Control Policy Date(s) previous version(s) approved (if known): Version: 1 2 3 4 5 5.1 5.2 Date: June 2007 November 2007 November 2007 June 2009 November 2010 February 2011 September 2011 DATE OF NEXT REVIEW: June 2014 Manager Responsible for Review: your hospitals, your health, our priority
June 2013 June 2016 AT ALL TIMES, STAFF MUST TREAT EVERY INDIVIDUAL WITH RESPECT AND UPHOLD THEIR RIGHT TO PRIVACY AND DIGNITY. Contents Page No. 1. Procedure Statement 2 2. Key Principles 2 3. Responsibilities 2 4. Limitations 3 5. Adult Empirical Treatment Guide 4 9 6. IV to Oral Switch Choice of Oral Agents 10 7. Human Rights Act 11 8. Accessibility Statement 11 9. Monitoring & Review 11 10. Equality Impact Assessment 11 Appendices App 1: Glossary of Terms 12
1. PROCEDURE STATEMENT 1.1 Antimicrobial management is a key component of infection prevention and control and prudent antimicrobial prescribing is key to reducing Clostridium difficile associated disease rates. 1.2 This SOP presents recommendations that, if implemented, will help reduce the risk of infection from Clostridium difficile and maintain the effectiveness of antimicrobial agents in the treatment of infections by reducing the risk of antimicrobial resistance developing. 1.3 This SOP should be implemented in conjunction with the policy for the Prescribing of Antimicrobials within the Acute Trust available on the Microbiology Intranet site. 2. KEY PRINCIPLES 2.1 This SOP supersedes all previous guidelines for adults and is designed to cover the majority of inpatient treatment within all Directorates for the indications listed below. 2.2 Specialised areas (Accident and Emergency, ICU, Obstetrics) to maintain their own guidelines but these to reflect the recommendations within the main document. 2.3 Cefuroxime, cefotaxime, clindamycin and ciprofloxacin should be avoided except in the circumstances indicated by this policy. 2.4 Treatment of most infections should not exceed seven days. 2.5 Intravenous antibacterial therapy should be reviewed after 48 hours. Depending on the clinical diagnosis antibiotics may no longer be indicated or an oral agent could be administered. 2.6 All antimicrobials should be reviewed after 5 days and rewritten if necessary. 2.7 Antimicrobial treatment should be modified according to microbiology laboratory results. 2.8 If patient is said to be allergic to an antibiotic, check and record the type and severity of reaction. For further information refer to Guidelines for the management of patients reporting a history of penicillin allergy available on the Microbiology Intranet site. 2.9 For further advice contact s: Dr C Faris ext: 2153 and Dr R Nelson ext: 2943. 3. RESPONSIBILITIES 3.1 It is the responsibility of all Clinical Divisional Chairs and consultants to disseminate the SOP to relevant staff 3.2 It is the responsibility of staff prescribing antimicrobial therapy to adhere to this policy. All staff should be aware of the current version of antibiotic SOP and how to access it. 3.3 It is the responsibility of the prescriber to clearly document on the drug board the indications, course length, stop date and review date at the time of prescribing the antimicrobial treatment. 3.4 is responsible to review the SOP regularly and make it available on the Intranet. 2
4. LIMITATIONS This SOP is not intended to be comprehensive. Prescribers are advised to consult the British National Formulary (BNF) and the manufacturer s summary of product characteristics for additional information. This is especially relevant for side effects, contraindications, interactions with other drugs and the use of antimicrobials in pregnancy. Advice about individual patients on clinical problems may be obtained from the Consultant Microbiologists: Dr C Faris ext 2153 or Dr R Nelson ext 2943, or via switchboard outside normal working hours. 3
5. ADULT EMPIRICAL TREATMENT GUIDE Condition Regimen Penicillin allergy/ Alternative regimens Uncomplicated lower UTI Nitrofurantoin # oral 50mg 6 hourly for 3-7 daysŧ. Patient with egfr < 60mls/min, co-amoxiclav oral 375mg 8 hourly for 3-7 daysŧ. OR Cefalexin oral 500mg 12 hourly for 3-7 daysŧ. Complicated UTI/Pyelonephritis Factors suggesting a complicated UTI: Male patients, pregnant, diabetes mellitus, renal tract abnormalities, recent urinary surgery/instrumentation (excluding urinary tract catheterisation), indwelling urinary catheter, symptoms persisting for over 7 days, recent broad spectrum antibiotics. Empirical co-amoxiclav oral 625mg (or IV 1.2g) 8 hourly + IV gentamicin* 7mg/kg/day. Duration of treatment: 7-14 days. Known sensitivity trimethoprim oral 200mg 12 hourly. Duration of treatment: 10 days. Gentamicin indicated if there are concerns of multi-drug resistant organisms. Severe sepsis associated with UTI Tazocin IV 4.5g 8 hourly + IV gentamicin* 7mg/kg/day. Ceftriaxone IV 1-2g once daily + IV gentamicin* 7mg/kg/day. Catheter-associated UTI (CAUTI) All catheters become colonised by bacteria and growth of organisms from a CSU is NOT an indication for antibiotic treatment in the absence of clinical evidence of infection. Symptoms suggestive of CAUTI New loin or suprapubic tenderness Rigors New onset delirium Fever >38 o C or 1.5 o C above baseline on two occasions during 12 hours. Send urine for culture only if clinically indicted by above symptoms. Obtain sample from new catheter and await culture results if possible. CAUTI with systemic features of sepsis (Systemically unwell 2 or more of following: Temp>38 or <36, HR >90, RR>20, WBC >12 or <4). Co-amoxiclav PO 625mg 8 hourly + gentamicin* IV 7mg/kg/day (max 560mg). Duration of treatment: 7 days. Gentamicin indicated if there are concerns of multi-drug resistant organisms. IV tazocin 4.5g 8 hourly + IV gentamicin* 7mg/kg/day. # Nitrofurantoin - Contraindicated if egfr <60ml/min. Ŧ For uncomplicated cystitis in women without a catheter give 3 days course; for all other patients give 7 days. Previous MRSA, hospital admission within 6 months, nursing home resident. Consult Microbiologist for advice if history of life threatening allergy to beta-lactams (e.g. anaphylaxis, angioedema, facial/throat swelling). * /Antimicrobial Pharmacist for dosing advice for patients with renal failure. 4
Condition Regimen Penicillin allergy/ Alternative regimens Cellulitis- Mild to moderate: Please follow the linked document below to go to Community Parenteral Antibiotic Therapy Guidelines U:\CAMELIA\Policies\ Community Parentera Flucloxacillin oral 500mg 6 hourly. For 7 days. Flucloxacillin IV 1-2g 6 hourly plus benzylpenicillin IV 1.2g 4-6 hourly. Clarithromycin oral 500mg 12 hourly. For 7 days. Teicoplanin IV 400mg every 12 hours for 3 doses then 400mg once daily. Severe with systemic symptoms: NB. Providing there is clinical improvement IVs should be continued until cellulitis subsides, then change to oral antibiotics for 5 further days. Cellulitis in patients with a history of MRSA colonisation or risk factors such as several hospital admissions within 6 months or nursing home resident. Pressure sores Uncomplicated. With progressing cellulitis: With progressing cellulitis and systemic symptoms: Teicoplanin IV 400mg every 12 hours for 3 doses then 400mg once daily. Pressure relief and wound toilet only. Flucloxacillin IV 1g (oral 500mg) 6 hourly ± metronidazole oral 400mg 8 hourly for 7 days. Tazocin IV 4.5g 8 hourly. (Add teicoplanin if at high risk of MRSA ). Ceftriaxone IV 1g once daily ± metronidazole oral 400mg 8 hourly for 7 days. (Add teicoplanin if at high risk of MRSA ) Ŧ For uncomplicated cystitis in women without a catheter give 3 days course; for all other patients give 7 days. Previous MRSA, hospital admission within 6 months, nursing home resident. Consult Microbiologist for advice if history of life threatening allergy to beta-lactams (e.g. anaphylaxis, angioedema, facial/throat swelling). 5
Condition Regimen Penicillin allergy/ Alternative regimens Diabetic foot Mild infection Cellulitis/ erythema < 2cm AND infection limited to skin or superficial subcutaneous tissue AND NO PREVIOUS antibiotic treatment. Diabetic foot Moderate infection Cellulitis extending >2cm OR Lymphangitis OR Deep tissue abscess OR failure of previous antibiotic. Diabetic foot Severe infection with systemic symptoms (fever, WBC, CRP), necrosis or osteomyelitis. Necrotising fasciitis MRSA Systemic or life-threatening infections. MRSA- Other infections. See MRSA Antibiotic Policy. MRSA- Colonization (nose, intact skin). Refer to MRSA Infection Control Policy. Flucloxacillin (oral or IV) 1g 6 hourly. For 1 2 weeks. Co-amoxiclav IV 1.2g (oral 625mg) 8 hourly. For 2-4 weeks. Tazocin IV 4.5g 8 hourly plus clindamycin IV 900mg 6 hourly. For 2-4 weeks. (Add teicoplanin if at high risk of MRSA ) Tazocin IV 4.5g 8 hourly plus clindamycin IV 900mg 6 hourly. Teicoplanin IV 10-12 mg/kg 12 hourly for 3 doses then 10-12 mg/kg once daily ± rifampicin oral 300-600mg 12 hourly. For 14 days. Consult Microbiologist for advice as these infections require combination therapy. Topical treatment with nasal Bactroban three times daily. Antiseptic skin wash (e.g. Octenisan or others) for daily bathing and shampooing. For 5 days. Clindamycin oral 450mg 6 hourly. For 1-2 weeks. Ciprofloxacin oral 750mg (IV 400mg) 12 hourly plus clindamycin oral 450mg (IV 600mg) 6 hourly. Ciprofloxacin IV 400mg (oral 750mg) 12 hourly plus clindamycin IV 900mg (oral 450mg) 6 hourly. (Add teicoplanin if at high risk of MRSA ) Ciprofloxacin IV 400mg 12 hourly plus clindamycin IV 900mg 6 hourly. Consult Microbiologist for advice. Consult Infection Control for advice. IV therapy until stable, then oral antibiotics for 2 to 4 weeks in the absence of osteomyelitis. Previous MRSA, hospital admission within 6 months, nursing home resident. 6
Condition Regimen Penicillin allergy/ Alternative regimens Bone and joint infections Flucloxacillin IV 2g 4-6 hourly plus gentamicin* IV 7mg/kg/day (IV for 2 weeks followed by oral antibiotic for further 4 weeks. Oral antibiotic choice depends on culture results and history). Teicoplanin IV 10-12mg/kg 12 hourly for 3 doses then same dose once daily plus gentamicin* IV 7mg/kg/day. Infective exacerbations of COPD Antibiotics indicated if 2 or more of the following: increase in purulence of sputum; increase in volume of sputum; increase in breathlessness. If consolidation on CXR treat as for pneumonia (see below). Non-pneumonic chest infections (both community and hospital acquired) Community-acquired pneumonia Evidence of consolidation on CXR. Clinical findings & severity rating using CURB-65 score must be documented: C = Confusion (AMTS<8) 1 point. U = Urea >7 1 point. R = Respiratory Rate >30 1 point. B = SBP <90 or DBP <60 1 point. 65 = Age >65 1 point. Collect sputum and blood cultures if pyrexial. Legionella urine antigen and nose and throat swabs (VTM) for respiratory viruses. Community-acquired aspiration pneumonia Doxycycline oral 200mg stat on day 1, then 100mg once daily for 6 days. If nil by mouth, co-amoxiclav IV 1.2g 8 hourly (convert to PO once taking oral medication) for 5 days. Patient not responding to or failed a recent course of doxycycline co-amoxiclav oral 625mg 8 hourly for 5 days Mild (CURB-65: 0-1): Amoxicillin oral 500mg 8 hourly for 5 days. Moderate CAP (CURB-65: 2): Amoxicillin 500mg-1g (oral or IV) 8 hourly plus clarithromycin oral 500mg 12 hourly for 7 days. Severe CAP (CURB-65: 3): Co-amoxiclav IV 1.2g 8 hourly plus clarithromycin (IV or oral) 500mg 12 hourly. Review IV after 48 hours. Duration 7-10 days. Contact Microbiologist. Trimethoprim oral 200mg 12 hourly for 5 days. Doxycycline oral 200mg stat on day 1, then 100mg 12 hourly for 6 days. OR clarithromycin oral 500mg 12 hourly for 5 days. Ceftriaxone IV 1g once daily plus clarithromycin oral 500mg 12 hourly for 7 days. Review IV after 48 hours. Ceftriaxone IV 1-2g once daily plus clarithromycin (IV or oral) 500mg 12 hourly. Review IV after 48 hours. Benzylpenicillin IV 1.2g 6 hourly plus metronidazole IV 500mg 8 hourly 7 days. Ceftriaxone IV 1g once daily plus metronidazole IV 500mg 8 hourly. Hospital-acquired aspiration pneumonia Tazocin IV 4.5g 8 hourly 7 days. Ceftriaxone IV 1-2g once daily plus metronidazole IV 500mg 8 hourly ± gentamicin* IV 7mg/kg/day. Consult Microbiologist for advice if history of life threatening allergy to beta-lactams (e.g. anaphylaxis, angioedema, facial/throat swelling). * /Antimicrobial Pharmacist for dosing advice for patients with renal failure. 7
Condition Regimen Penicillin allergy/ Alternative regimens Hospital-acquired pneumonia Tazocin IV 4.5g 8 hourly 7 days. Ceftriaxone IV 1-2g once daily ± gentamicin* IV 7mg/kg/day. Clostridium difficile infection (CDI) Review concurrent antibiotic treatment, PPIs or laxatives and discontinue them where possible. Initial episode in patient age <75 years with NO severe co-morbidities Initial episode in patient age 75 years and/or with severe co-morbidities (immunocompromise, organ failure) Metronidazole oral/ NG 400mg 8 hourly for 10-14 days. Vancomycin oral/ NG 125mg 6 hourly for 10-14 days. If oral route is compromised: metronidazole IV 500mg 8 hourly for 10-14 days. Severe CDI Life threatening CDI (hypotension, partial or complete ileus or toxic megacolon or CT evidence of severe disease). For full details, please refer to Clostridium difficile infection: Treatment on Microbiology Intranet site. Bacterial Meningitis Consider if prophylaxis is required (see prophylaxis guidelines). Viral Encephalitis (Herpes simplex) Vancomycin oral/ NG 125 6 hourly for 10-14 days. If no clinical response, dose may be increased to a max 500mg qds. Vancomycin oral/ng 500mg 6 hourly for 10 14 days plus metronidazole IV 500mg 8 hourly. If ileus is present, then add vancomycin as a retention enema (500mg in 100ml normal saline per rectum 6 12 hourly). Ceftriaxone IV 2g 12 hourly (plus amoxicillin IV 2g 4 hourly if age >50 or immunocompromised). Duration of course is variable. Aciclovir IV 10mg/kg 8 hourly. For 14 21 days. If oral route is compromised: Metronidazole IV 500mg 8 hourly for 10 to 14 days plus intracolonic vancomycin 500mg in 100ml of normal saline every 6 to 12 hours and/or vancomycin 500mg 6 hourly by nasogastric tube. Chloramphenicol IV 25mg/kg 6 hourly. If at risk of penicillin-resistant pneumococcus, add vancomycin IV 1g 12 hourly. Consult Microbiologist for advice if history of life threatening allergy to beta-lactams (e.g. anaphylaxis, angioedema, facial/throat swelling). * /Antimicrobial Pharmacist for dosing advice for patients with renal failure. 8
Condition Regimen Penicillin allergy/ Alternative regimens Endocarditis Indolent presentation (Streptococcus spp) Acute presentation (Staphylococcus spp) Prosthetic valve endocarditis. Suspected MRSA. Endocarditis in injecting drug user. Sepsis Associated with Benzylpenicillin IV 1.2g 4 hourly for 4 weeks ± gentamicin* IV 1mg/kg 8 hourly for 2 weeks. Flucloxacillin IV 2g 4-6 hourly for 4 weeks plus gentamicin* IV 1mg/kg 8 hourly for 5 days. Vancomycin IV 1g 12 hourly for 6 weeks plus gentamicin* IV 1mg/kg 8 hourly for 2 weeks plus rifampicin oral 600mg 12 hourly 6 weeks. Vancomycin IV 1g 12 hourly for 4 weeks plus gentamicin* IV 1mg/kg 8 hourly for 2 weeks. Check vancomycin and gentamicin serum levels. Urinary tract: Intra-abdominal source: Tazocin IV 4.5g 8 hourly ± gentamicin* IV 7mg/kg/day. Tazocin IV 4.5g 8 hourly± gentamicin* IV 7mg/kg/day. Ceftriaxone IV 2g once daily ± gentamicin* IV 7mg/kg/day. Tigecycline IV 100mg once then 50mg 12 hourly ± gentamicin* IV 7mg/kg/day. Febrile Neutropenia - High-risk patient: Meropenem IV 1g 8 hourly ± (teicoplanin IV 400mg every 12 hours x 3 doses, then 400mg once daily). Indications for teicoplanin: severe mucositis, h/o ciprofloxacin prophylaxis, IV catheter related sepsis, MRSA colonisation. Consult Microbiologist. - Low-risk patient: See Trust guidelines for Management of Adults with Neutropenia. Chest infection: See recommendations for severe CAP or HAP. Skin/soft tissue infection: No source identified: Flucloxacillin IV 1-2g 6 hourly plus benzylpenicillin IV 1.2g 4-6 hourly. Tazocin IV 4.5g 8 hourly ± gentamicin* IV 7mg/kg/day. (Add Teicoplanin to all above if at high risk of MRSA ) Teicoplanin IV 400mg every 12 hours for 3 doses then 400mg daily. Teicoplanin IV 10-12mg/kg every 12 hours for 3 doses then 10-12mg/kg daily plus gentamicin* IV 7mg/kg/day plus metronidazole IV 500mg 8 hourly. Previous MRSA, hospital admission within 6 months, nursing home resident. Consult Microbiology for advice if history of life threatening allergy to beta-lactams (e.g. anaphylaxis, angioedema, facial/throat swelling). * /Antimicrobial Pharmacist for dosage advice for patients with renal failure. 9
6. IV TO ORAL SWITCH CHOICE OF AGENTS IV to Oral Switch Choice of Oral Agents IV Agent Oral Alternative Review antibiotic therapy after 48 hours. Stop if infection has been ruled out. In the absence of microbiology switch to oral antibiotic when signs of sepsis are resolving and the oral route is not compromised. Specific contraindications to oral switch o Meningitis o Endocarditis o Joint and bone infections Tazocin 4.5g TDS Ciprofloxacin 400mg BD Co-amoxiclav 1.2g TDS Clindamycin 900mg QDS Teicoplanin Flucloxacillin 1-2g QDS Benzylpenicillin 1.2g QDS Ceftriaxone 2g BD (meningitis) Ceftriaxone 1-2g OD Gentamicin Tigecycline (intra-abdominal sepsis) Meropenem 1g TDS Co-amoxiclav 625mg TDS Ciprofloxacin 750mg BD Co-amoxiclav 625mg TDS Clindamycin 450mg QDS Consult Microbiologist. Flucloxacillin 500mg QDS Amoxicillin 500mg TDS No oral switch. Complete IV course. Consult Microbiologist. Consult Microbiologist. Ciprofloxacillin 500mg BD + metronidazole 400mg TDS Consult Microbiologist. 10
7. HUMAN RIGHTS ACT Implications of the Human Rights Act have been taken into account in the formulation of this policy and they have, where appropriate, been fully reflected in its wording. 8. ACCESSIBILITY STATEMENT This document can be made available in a range of alternative formats e.g. large print, Braille and audiocassette. Form more details please contact HR Department on 01942 77(3766) or email equalityanddiversity@wwl.nhs.uk 9. AUDIT MONITORING AND REVIEW: The processes contained within this SOP will be; audited, monitored and reviewed in line with the audit and monitoring template contained within Antimicrobial Prescribing Policy TW10-136. 10. EQUALITY AND DIVERSITY ASSESSMENT: The completed assessment is contained within the associated Antimicrobial Prescribing Policy TW10-136. 11
APPENDIX 1 GLOSSARY OF TERMS AXR BD BNF CAP CAUTI COPD CRP CURB 65 CXR HAP ICU IV Kg Mg MRSA OD PO QDS TDS UTI WBC Abdominal x-ray Twice a day British National Formulary Community acquired pneumonia Catheter-associated UTI Chronic obstructive pulmonary disease C-reactive protein Index for measuring severity of CAP by assessing for presence of Confusion, serum urea, respiratory rate, blood pressure and age Chest x-ray Hospital acquired pneumonia Intensive care unit Intravenous Kilogram Milligram Methicillin resistant staphylococcus aureus Once a day By mouth Four times a day Three times a day Urinary tract infection White blood cell 12