Bevan 2003

Methods	Randomized, open‐label, comparative, multicentre, and multinational trial.
Participants	Inclusion criteria: aged ≥ 18 years, fulfilling Hager's criteria for a clinical diagnosis of acute PID (Hager 1983), and requiring hospitalization for treatment. Diagnosis of acute PID confirmed by laparoscopy unless impossible due to need for immediate treatment. Exclusion criteria: palpable tubo‐ovarian abscess (i.e. ultrasound diameter ≥ 5 cm); use of additional antimicrobial therapy for a concurrent infection; use of antibiotic therapy during the preceding 2 weeks; terminal illness; immunosuppression; impaired gastrointestinal function or absorption (or both); hepatic or renal impairment; known allergy to macrolides, tetracycline, metronidazole, penicillin, cephalosporins, or clavulanic acid; use of oral hypoglycaemic drugs, ergot, dicoumarin anticoagulants, carbamazepine, ciclosporin, digoxin, or theophylline; and known drug addiction, alcoholism, or taking of recreational drugs. Number of women randomized: 310. Number of women analyzed: 309; group A: 106; group B: 107; group C: 96. Number of withdrawals/exclusions/loss to follow‐up and reasons: 10 patients were excluded from the analysis at end of treatment because of the following protocol violations: did not receive study medication (n = 1); inappropriate primary diagnosis (n = 2); concomitant antibacterial treatment (n = 1); no signs/symptoms recorded at day evaluation (n = 1); and missing data or mistimed evaluation (n = 5). Number of centres: multiple, but the authors did not specify how many. Age (mean (range)) (years): group A: 28.4 (18‐54); group B: 27.6 (18‐46); group C: 27.6 (17‐54). Country: UK and others that were not stated.
Interventions	Group A: azithromycin 500 mg IV single dose, days 2‐7: 250 mg PO once daily or days 1‐2: azithromycin 500 mg IV once daily; days 3‐7: 250 mg PO once daily. Group B: as group A + day 1: metronidazole 500 mg IV 3 times daily or 400 mg PO 3 times daily, days 2‐12: metronidazole 400 mg PO 3 times daily or days 1‐2: azithromycin 500 mg IV once daily; days 3‐7: 250 mg PO once daily plus day 1‐2: metronidazole 500 mg IV 3 times daily, or 500 mg PO 3 times daily. Days 3‐12: metronidazole 500 mg PO 3 times daily or days 1‐21: metronidazole 500 mg PO 3 times daily. Group C: day 1: metronidazole 500 mg IV 3 times daily, or metronidazole 400 mg PO 3 times daily; day 2‐12: metronidazole 400 mg PO 3 times daily + days 1‐14: cefoxitin 2 g IV or IM 4 times daily + day 1: probenecid 1 g PO single dose or day 1‐21: doxycycline 100 mg PO twice daily + day 1‐5: amoxicillin/clavulanate 1 g IV + times daily; day 6‐21 amoxicillin/clavulanate 500 mg PO 3 times daily.
Outcomes	Clinical response to treatment: cure, resolution of all baseline signs and symptoms; improvement, lessening of the baseline signs and symptoms or absence of ≥ 1, but not all, of the baseline findings; or failure, no improvement or deterioration of baseline condition. Successful clinical outcome defined as cure or improvement. Assessment on day 15 (9‐26 inclusive) and at follow‐up (day 35‐44). Microbiological outcome: eradication, absence of the baseline isolate(s); persistence, presence of baseline isolate(s); or superinfection, presence of a micro‐organism different from that found at baseline.
Notes	Ethical approval: yes "European Ethical Review Committee and by local hospital ethical committees." Informed consent: yes, prior to entry into either study, written informed or witnessed oral consent was obtained from each woman. Source of funding: not stated, but 1 the authors was from Pfizer Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Women randomized to 1 of 3 treatment groups.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition rate (< 20%).
Selective reporting (reporting bias)	Unclear risk	No trial protocol found.
Other bias	Unclear risk	Trial had support of pharmaceutical industry. 1 case missing from the analysis and not specified in the report.