Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: women aged ≥ 18 years hospitalized with 1 of the following conditions: endometritis, myometritis, postoperative infections in pelvic region, pelvic peritonitis, acute adnexal infections such as salpingitis or pyosalpinx. Exclusion criteria: allergy to clindamycin, lincomycin, metronidazole, or gentamicin; colitis when taking antibiotics; taken antibiotics in the 48 h before entering study; pregnant or lactating; vestibular or cochlear lesion; renal insufficiency (creatinine > 12 mg/L; WBC < 2000/mm2; platelets < 100,000/mm3; history of thrombopathy; peripheral neuropathy; participation in another clinical trial. Number of women randomized: 45; group A: 23; group B: 22. Number of women analyzed: 39; group A: 21; group B: 18. Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 2; group B: 4. All unexplained. Number of centres: 2. Age (mean ± SD) (years): group A: 27.9 ± 5.2; group B: 29.1 ± 9.5. Country: France. |
|
Interventions |
Group A: clindamycin 900 mg IV every 8 h diluted in 150 mL (minimum volume) saline slow perfusion (30‐60 minutes) + gentamicin 1 mg/kg IM every 8 h (with minimum dose prescribed of 60 mg every 8 h, according to bodyweight). Treatment given for minimum of 5 days in hospital. Clindamycin perfusion not stopped until 48 consecutive h with temperature below 37.5 °C; at that point treatment could be PO. Maximum length of treatment at the discretion of the therapist. If also treated with a tetracycline, this was not prescribed < 48 h after the end of the treatment protocol (either clindamycin + gentamicin or metronidazole + gentamicin). Group B: metronidazole 500 mg every 8 h in slow IV perfusion (30‐60 minutes) + gentamicin 1 mg/kg IM every 8 h (with minimum dose prescribed of 60 mg every 8 h, according to bodyweight). Treatment given for 6 weeks. |
|
Outcomes |
Primary outcome: clinical cure: absence of infection in the days following cessation of treatment according to clinical observations, microbe eradicated during or after treatment. Secondary outcome: length of hospital stay. |
|
Notes |
Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported. Mean days of hospitalization: 11.17 days. |
|
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 | 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 | Attrition < 20%. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol found. |
Other bias | Unclear risk | Not stated. |