| Methods |
Randomized trial
Study period: not stated |
| Participants |
Inclusion criteria: women with pelvic cellulitis after hysterectomy or postpartum endometritis (defined as temperature of at least 38.3 °C after the first 24 hours and after cesarean birth and fundal tenderness, parametrial tenderness, and purulent lochia)
Setting: multicenter, USA
Number of participants: n = 579 (404 with postpartum endometritis) |
| Interventions |
Clindamycin 900 mg iv every 8 hours (n = 242; 202 postcesarean birth) plus aztreonam 1 g iv every 8 hours vs trospectomycin 500 mg iv every 8 hours (n = 243; 200 postcesarean birth) plus aztreonam 1 g iv every 8 hours |
| Outcomes |
Treatment failure (postcesarean birth women with endometritis provided separately)
For other outcomes (wound infection, serious complications, diarrhea) the results for endometritis postcesarean birth were not reported separately and have not been included
The 1 serious complication observed was septic thrombophlebitis in the trospectomycin group |
| Notes |
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomization table by pharmaceutical sponsor |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
States “double‐blinded” without further description |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
“Forty‐nine patients from the trospectomycin group and 45 from the clindamycin group were excluded for the efficacy evaluation. The reasons for exclusion included protocol violations as well as use of concomitant antibiotic, and other foci of infection”‐ balanced in numbers over both arms but numbers are high (30%) and the reasons for exclusion given could be related to true outcome |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ explicit |
