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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized controlled trial.
Participants Inclusion criteria: upper genital tract infection, pelvic pain (bilateral, unilateral), fever > 37.5 °C, leukorrhoea, bleeding, digestive and urinary signs, pain in right hypochondrium. Diagnosis confirmed by laparoscopy.
Exclusion criteria: pregnant or likely to be; allergy to penicillin or cephalosporins; receiving concomitant treatment with allopurinol; already received an antibiotic before admission; renal insufficiency.
Number of women randomized: 40; 20 in each group.
Number of women analyzed: 40; 20 in each group.
Number of withdrawals/exclusions/loss to follow‐up and reasons: 1 woman withdrawn during hospital admission; 13 women lost to follow‐up.
Number of centres: 1.
Age (mean (range)) (years): group A: 27.5 (17‐39); group B: 22.5 (17‐34).
Country: France.
Interventions Group A: amoxicillin‐clavulanate 1 g slow IV perfusion every 8 h. PO once temperature normal for 48 h, 4 tablets of 500 mg, 2 at a time as long as hospitalized. After discharge, treatment continued with 3 tablets daily of amoxicillin‐clavulanate for 3 weeks.
Group B: penicillin G 10 million units/24 h IV, followed by penicillin V PO + gentamicin 160 mg/24 h IM for 10 days + metronidazole 500 mg IV 3 times daily followed by metronidazole 500 mg PO 3 times daily.
Duration of treatment unclear.
Outcomes Effectiveness: cure: absence of pelvic pain on examination and referred by women, normal body temperature at discharge and 3 weeks later.
Adverse events: any antibiotic‐related adverse event leading to discontinuation of therapy during hospital stay and after 30 days.
Notes Ethical approval: not stated.
Informed consent: not stated.
Source of funding: not stated, and no conflicts of interest reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding of participants and personnel (performance bias) All outcomes High risk Open trial.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated.
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not stated.
Selective reporting (reporting bias) Unclear risk Not stated.
Other bias Unclear risk Not possible to identify.