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 Number of withdrawals/exclusions/loss to follow‐up and reasons: 1 woman withdrawn during hospital admission; 13 women lost to follow‐up.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. |
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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. |
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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. |
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Notes |
Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported. |
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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. |