Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: women of reproductive age who had clinical features of PID, acute salpingitis, or suspected pelvic abscess, such as lower abdominal pain associated with fever and chills, and cervical motion tenderness with or without signs of adnexal masses; required hospitalization for IV antibiotic therapy. In all cases, CDC criteria for PID satisfied. Exclusion criteria: suspected or known to be pregnant; breastfeeding. Number of women randomized: 71; group A: 35; group B: 36. Number of women analyzed: 61; group A: 31; group B: 30. Number of withdrawals/exclusions/loss to follow‐up and reasons: 10 women; group A: 4; group B: 6 later excluded from evaluation due to wrong diagnosis or protocol violations. Number of centres: not stated. Age (mean (range)) (years): group A: 27.5 (15‐37); group B: 26.5 (19‐36). Country: not stated. |
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Interventions |
Group A: ciprofloxacin 300 mg IV twice daily for ≥ 3 days followed by ciprofloxacin 500 mg PO twice daily for about 1 week. Group B: clindamycin 600 mg IV every 6 h + gentamicin 80 mg IV every 8 h, administered separately. Clindamycin by IV route for 3 days, followed by oral administration for about 1 week. Gentamicin dose adjusted based on serum creatinine and gentamicin levels. |
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Outcomes |
Primary outcomes: clinical cure: when there was resolution or clearing (or both) of signs of infection as evidenced by defervescence, reversal of leukocytosis, and abatement of abdominal pain and cervical motion tenderness; adverse events leading to discontinuation of therapy. Secondary outcome: length of hospital stay. |
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Notes |
Ethical approval: study protocol approved by the Human Rights Committee of their institution. Informed consent: yes, all women entered in study were informed in full and required to read and sign a consent form. Source of funding: supported by Miles Laboratory, New Haven, CT, a subsidiary of Bayer, Leverkusen, West Germany. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used a computer‐generated randomization scheme. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10/71 women not analyzed (14%). |
Selective reporting (reporting bias) | Unclear risk | No trial protocol found. |
Other bias | Unclear risk | Not stated. |