| Methods |
RCT
Assessor blinded
1995‐1996 |
| Participants |
Number: 380 patients (400 episodes)
Age: No data |
| Interventions |
cefepime 2grx2
versus
imipenem 1grx3 |
| Outcomes |
Overall and infection‐related mortality ‐ at 7 days after end of treatment
Clinical and microbiological failure
Adverse events |
| Notes |
MC France |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Patients were randomized using a centralized computer network system, stratified by centre and by first or second inclusion |
| Allocation concealment? |
Low risk |
Centralized computer network system |
| Blinding?
All outcomes |
High risk |
All 400 cases were reviewed by the study steering committee in a blinded fashion |
| Incomplete outcome data addressed?
All‐cause mortality |
High risk |
1% dropouts |
| Incomplete outcome data addressed?
Treatment failure |
High risk |
Number of dropouts (17%) known per study group |
| Free of other bias? |
High risk |
Unit of randomization = episodes; patients to episodes ratio 0.95 |
