Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: none stated. Exclusion criteria: none stated. Number of women randomized: 60; 30 in each group. Number of women analyzed: 60; 30 in each group. Number of withdrawals/exclusions/loss to follow‐up and reasons: 0 reported as lost to follow‐up. Number of centres: 1. Age (mean ± SD) (years): group A: 24.2 ± 5.1; group B: 24.7 ± 7.2. Country: US. |
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Interventions |
Group A: moxalactam 2 g IV every 8 h. Group B: clindamycin 600 mg IV every 6 h + tobramycin 1.5 mg/kg every 8 h. |
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Outcomes |
Primary outcome: microbiological cure. Secondary outcome: length of hospital stay. |
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Notes |
Ethical approval: not stated. Informed consent: yes, all women gave informed consent approved by the University of California (San Francisco) Committee on Human Research. 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) | Low risk | Women randomized using a computer‐generated randomized schedule. |
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 | All women randomized were analyzed. |
Selective reporting (reporting bias) | Unclear risk | No study protocol found. |
Other bias | Unclear risk | Not stated. |