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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
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.