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1 Antibiotic Guidelines: Obstetric Anti-Infective Prescribing Guidelines Classification: Clinical Guideline Lead Author: Antibiotic Steering Committee Additional author(s): Kelly Alexander / Frances Garraghan / Dr Ahmed Qamruddin / Dr Melissa Whitworth / Dr Teresa Kelly from Central Manchester Foundation Trust Hospitals. Authors Division: DCSS & Tertiary Medicine Unique ID: 144TD(C)25(J2) Issue number: 3 Expiry Date approved: October 2018 Contents Section Page Intro Who should read this document 2 Key practice points 2 Background 2 Guideline Empiric treatment for unknown source of maternal infection / sepsis 4 Treatment of a secondary postpartum haemorrhage due to retained 5 products Intra-abdominal infections 5 Urinary tract infections 6 Post-operative wound infection post delivery 6 Mastitis / breast abscess 7 Genitourinary infections 7 Gentamicin in pregnancy 7 Standards 8 Roles and Responsibilities 8 Appendix 9 Document control information (Published as separate document) 11 Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Page 1 of 11

2 Who should read this document? This policy applies to all clinical staff involved the prescribing of antimicrobials. NB These guidelines are based on the Central Manchester Foundation Trust Obstetrics anti-infective Prescribing guideline and are for patients receiving care at Salford Royal NHS Foundation Trust (inpatient or emergency department). If the patient is on the midwife-led unit then they should be managed according to Central Manchester antibiotic guidelines. Key Practice Points The recommendations below consider safety during pregnancy. For ladies who have given birth, the general Trust antibiotic guidelines may be followed, with consideration on safety in breast feeding if applicable. Contact Pharmacy or Medicines Information (ext 65223) for further advice. When considering treatment with antibacterial agents during pregnancy, the following factors should be considered: the severity of the maternal infection, the effects of any fever present on the pregnancy, the effects of failing to treat the mother, and the potential fetotoxicity of the drugs to be used. Where possible, the results of culture and sensitivity tests should be available before making a treatment choice, however treatment should NOT be delayed in patients who are unwell or septic. Administration of intravenous broad spectrum antibiotics is recommended within one hour of suspicion of severe sepsis, with or without septic shock. If genital tract sepsis is suspected, prompt early treatment with a combination of highdose broad spectrum intravenous antibiotics may be lifesaving. Breastfeeding This document is not a resource for determining antibiotic safety in breastfeeding. Do not assume if potential toxicity in breastfeeding has not been highlighted that the drug is safe in this situation. Please refer to medicines information for further information. Page 2 of 11

3 Background Antimicrobial agents are among the most commonly prescribed drugs and account for 20% of the hospital pharmacy budget. Unfortunately, the benefits of antibiotics to individual patients are compromised by the development of bacterial drug resistance. Resistance is a natural and inevitable result of exposing bacteria to antimicrobials. Good antimicrobial prescribing will help to reduce the rate at which antibiotic resistance emerges and spreads. It will also minimise the many side effects associated with antibiotic prescribing, such as Clostridium difficile infection. It should be borne in mind that antibiotics are not needed for simple coughs and colds. In some clinical situations, where infection is one of several possibilities and the patient is not showing signs of systemic sepsis, a wait and see approach to antibiotic prescribing is often justified while relevant cultures are performed. This document provides treatment guidelines for the most common situations in which antibiotic treatment is required. The products and regimens listed here have been selected by the Trust's Medicines Management Group on the basis of published evidence. Doses assume a weight of 60-80kg with normal renal and hepatic function. Adjustments may be needed for the treatment of some patients. This document provides treatment guidelines for the appropriate use of antibiotics. The recommendations that follow are for empirical therapy and do not cover all clinical circumstances. Alternative antimicrobial therapy may be needed in up to 20% of cases. Alternative recommendations will be made by the microbiologist in consultation with the clinical team. This document refers to the treatment of adult patients (unless otherwise stated). Please refer to up to date BNF/SPC for a full list of cautions, contra-indications, interactions and adverse effects of individual drugs. What is new in this version? Table format changed in line with CMFT guidance For intra-abdominal infections and post-operative wound infections, gentamicin to be added only if severe sepsis or septic shock in line with CMFT guidance. Previously advice was to add if 2 or more SIRs criteria present. Summary of safety information for antibiotics in pregnancy updated to include antibiotics that should be avoided. Page 3 of 11

4 NB These guidelines are based on the Central Manchester Foundation Trust Obstetrics anti-infective Prescribing guideline and are for patients receiving care at Salford Royal NHS Foundation Trust (inpatient or emergency department). If the patient is on the midwife-led unit then they should be managed according to Central Manchester antibiotic guidelines. Guideline Empiric treatment for unknown source of maternal infection / sepsis IV treatment Infection First line Alternative option Penicillin allergy crossover risk Maternal sepsis (unknown origin) Clinically stable Maternal sepsis Severe sepsis, septic shock Co-amoxiclav 1.2g tds 500mg tds if intraabdominal collection suspected Piperacillin/ tazobactam 4.5g tds 500mg tds if intraabdominal collection suspected Cefuroxime 1.5g tds 500mg tds Beta-lactam free option Clindamycin 600mg qds 500mg tds gentamicin stat First line Co-amoxiclav 625mg tds 400mg tds if intraabdominal collection suspected Choose appropriate route based on clinical condition Meropenem 1g tds Clindamycin 600mg qds 500mg tds gentamicin IV Step down based on culture and sensitivity results Oral treatment Beta-lactam free option No ideal oral options; consider completion of IV antibiotic course. Clindamycin 450mg IV/po qds ciprofloxacin 500mg orally bd may be used where benefit outweighs risk. First dose of antibiotics should be given within 1 hour. Consider risk of MRSA and consult microbiology if needed. Consider a stat dose of gentamicin IV (see 4.10) review at 24 hours Total duration Review at 24 hours. If no improvement discuss with microbiology ext Out of hours via switchboard Total course length 7-10 days Review at 24 hours. If no improvement at 24 hours discuss with microbiology ext Out of hours via switchboard Total course length 7-10 days Page 4 of 11

5 Treatment of a secondary postpartum haemorrhage due to retained products Refer to empiric treatment for unknown source of maternal infection / sepsis. Intra-abdominal infections ***NB*** Please note that the following treatment guideline for intra-abdominal infections refer to treatment in pregnant women ONLY. For the Trust policy on intra-abdominal sepsis in other patient groups, click here. Intra-abdominal sepsis 1st line 2nd line Non-response to first line Recent ITU admission Likely pseudomonas infection 1 st Line Alternative option Penicillin allergy cross-over risk Co-amoxiclav IV 1.2g tds IV 500mg tds if collection present Piperacillin / tazobactam IV 4.5g tds 3 rd line Meropenem IV 1g tds Only after discussion with microbiology Oral continuation Co-amoxiclav 625mg tds IV 500mg tds if collection present Cefuroxime 1.5g IV tds 500mg IV tds Beta-lactam free option Clindamycin 600mg IV or 450mg po qds gentamicin IV (see section 4.10) Discuss with microbiology Duration 5-10 days therapy, but may be longer (e.g. liver abscess, 4-6 weeks) Consider adding gentamicin IV stat if severe sepsis or signs of septic shock (Review at 24 hours) No ideal oral options consider completion of IV 5-10 days therapy, but may be longer antibiotic course. (e.g. liver abscess, 4-6 weeks) Clindamycin 450mg po qds ciprofloxacin 500mg po bd may be used where benefit outweighs risk Page 5 of 11

6 Urinary tract infections For the treatment of Urinary Tract Infections, refer to trust policy. The policy includes a specific section for the treatment of urinary tract infections in pregnancy. Post-operative wound infection post delivery Clean- contaminated surgery Contaminated/dirty surgery 1 st line Contaminated/dirty surgery 2 nd line: (Non-response to 1 st line) Oral continuation MRSA skin colonisation 1 st Line Alternative option Penicillin allergy cross-over risk Flucloxacillin IV or PO IV 1-2g qds or PO 500mg qds Co-amoxiclav IV or PO IV 1.2g tds or PO 625mg tds Cefuroxime IV 1.5g tds 500mg IV tds Beta-lactam free option Duration Clarithromycin 500mg IV or po bd Total duration 5 to 7 days Clarithromycin 500mg IV bd According to response 500mg IV tds 7-14 days Piperacillin / tazobactam IV 4.5g tds Meropenem IV1g tds Clarithromycin 500mg IV bd ciprofloxacin 500mg po bd 500mg IV tds OR Clindamycin 450mg IV/po bd ciprofloxacin 500mg po bd Consider adding gentamicin IV stat (see 4.10) if severe sepsis or signs of septic shock (Review at 24 hours) Modify this according to response & culture / sensitivity results. Add / substitute (for flucloxacillin) IV teicoplanin 400mg Page 6 of 11

7 Mastitis / breast abscess Mastitis / breast abscess 1 st line 2 nd line / mixed infection 1 st Line Alternative option Penicillin allergy cross-over risk Flucloxacillin IV or PO IV 1-2g qds or PO 500mg qds Co-amoxiclav IV or PO IV 1.2g tds or PO 625mg tds Oral: Cefalexin 500mg tds IV: Cefuroxime 1.5g tds Beta-lactam free option Clarithromycin 500mg IV or PO bd Plus 500mg IV / 400mg po tds for mixed infection or failure to respond to 1 st line Discuss with microbiology Duration Up to 2 weeks if abscess present or as clinically indicated Genitourinary infections Please refer to the Trust s Treatment Management Protocols for Sexually Transmitted Infections. Gentamicin in pregnancy Neonatal ototoxicity has not been observed with use of gentamicin in pregnancy however it has been seen with other aminoglycosides, therefore gentamicin should be used with caution in pregnancy. Where possible use only a stat dose or the shortest effective course. For guidance on dosing gentamicin, please refer to the Trust policy on Once Daily Gentamicin Dosing. Please note that in pre-eclampsia, gentamicin clearance is reduced and levels should be checked daily. Page 7 of 11

8 Standards Document the Indication/rationale for antimicrobial therapy, including clinical criteria relevant to this. Review and document the patient s allergy status Ensure the choice of antibiotic complies with the antibiotic guidelines and you have documented any clinical criteria relevant to the choice of agent. Document a management plan including a stop or review date. Where relevant, consider drainage of pus or surgical debridement/removal of foreign material. Explanation of terms & Definitions Not applicable Roles and responsibilities All clinical staff involved in the prescribing of antimicrobials to adhere to this policy including full documentation on EPMAR as detailed. Page 8 of 11

9 Appendices Summary of safety information for antibiotics in pregnancy Drugs considered safe for routine use in pregnancy Antibiotic class Examples Safety in Details pregnancy Penicillins Amoxicillin First line Co-amoxiclav First line No adverse effects have been attributed in studies of amoxicillin and clavulanate in pregnant women. Pipercillin / tazobactam Suitable for use in severe Limited human data. Animal data suggests Non-severe delayed:. Cephalosporins Macrolides Cefalexin Cefotaxime Ceftriaxone Cefuroxime Erythromycin (excluding estolate salt) infections. First line Second line to penicillins or cephalosporins. Available data does not indicate an increased risk of congenital malformations / adverse fetal effects. Has been extensively used in pregnancy. Standard treatment for pre-term premature rupture of membranes Metronidazole Clarithromycin Erythromycin preferred due to limited data for clarithromycin. Has been extensively used in pregnancy. To date, exposure to during pregnancy has not been associated with teratogenic effects. Mutagenic and carcinogenic in some animal studies. Available data, in humans does not indicate an increased risk of adverse fetal effects. High dose regimens e.g. 2g stat are generally not recommended Page 9 of 11

10 Reserve antibiotic agents or caution in pregnancy Antibiotic class Examples Safety in Details pregnancy Carbapenems Meropenem Reserved for serious or life-threatening infections. Limited human data. Animal data does not indicate direct or indirect harmful effects with respect to reproductive toxicity Ertapenem No human studies. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or post-natal development. Clindamycin Fosfomycin Imipenem Use meropenem Limited human data May be used in pregnancy for indicated infections. Strictly microbiology only agent. Non-severe delayed: to fetus, may be used in pregnancy for indicated infections Glycopeptides Vancomycin May be used in pregnancy for indicated infections Ensure strict monitoring of levels Pivmecillinam (Note this is a penicillin) Microbiology only agent. No reports of congenital defects identified. Number of published reports in humans, including 1 st trimester, without apparent harm to newborn No reports of congenital defects. Potential risk of ototoxicity if recommended plasma levels exceeded Crosses placenta. Limited data in UK texts. Extensively used in Scandinavian countries (first line agent). Cohort studies do not suggest an increase in malformations. One cohort study concluded pivmecillinam was associated with an increased risk of miscarriage compared to control (but not a comparator agent). The study design did not allow conclusions as to whether risk was associated with infection or drug exposure. Page 10 of 11

11 Avoid in pregnancy unless other treatment options unsuitable limited data or associated with toxicity. Prescribe only after discussion with microbiology Antibiotic class Examples Safety in Details pregnancy Aminoglycosides Gentamicin Reserved for treatment of serious or life-threatening conditions unresponsive to standard therapy Limited data in humans does not indicate an increased teratogenic risk. Theoretical concerns of fetal ototoxicity and nephrotoxicity. Topical preparations (eye or ear drops) are not expected to be risk. Colomycin (Colistin) Avoid Glycopeptides Teicoplanin Vancomycin is preferred due to limited data for teicoplanin Nitrofurantoin Avoid AT TERM (from 37 weeks) as per BNF Quinolones Ciprofloxacin Reserved for serious or life-threatening infections unresponsive to standard therapy Temocillin Tetracyclines Trimethoprim Doxycycline Tetracycline Oxytetracycline No human data. Avoid unless no alternative treatment option Avoid Avoid in 1 st trimester If essential, supplement with folic acid 5mg od Limited data. No reports of congenital defects. Toxicity observed in rabbit embryos Limited information. Limited safety data; rare but severe adverse effects have been reported. Risk of causing haemolytic anaemia in newborn. May be considered in early pregnancy if 1 st line agents cannot be used. Limited safety data. Theoretical risk of arthropathy in infant. Not recommended except for the treatment of serious or lifethreatening conditions unresponsive to standard therapy. Ciprofloxacin is the agent of choice if essential. No human data. No teratogenic effect in animal studies. Use in the second or third trimester can cause discolouration of teeth, bones and staining of the lenses. May be associated with cataracts. Risk of neural tube defects due to folate deficiency in first trimester. May be used in 2 nd or 3 rd trimester Page 11 of 11

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