Methods |
RCT
Assessor blinded
1990‐1993 |
Participants |
Number: 407 patients (457 episodes)
Age: med 51, range 17‐84 |
Interventions |
imipenem 500mg/m2x
versus
cefoperazone 2gr sulbactam 1grx3 |
Outcomes |
Clinical and microbiological failure
Superinfection
Adverse events |
Notes |
USA |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Computer‐generated sequence |
Allocation concealment? |
Low risk |
Patients were randomly assigned by the pharmacy and randomization was performed by the pharmacy after the patient was entered |
Blinding?
All outcomes |
High risk |
The physicians caring for the patients were aware of the antibiotic regimen assigned. Evaluation was conducted by investigators not involved in the patient's care and who were blinded to the therapeutic regimen and identity of the patient. |
Incomplete outcome data addressed?
All‐cause mortality |
Unclear risk |
Mortality not reported |
Incomplete outcome data addressed?
Treatment failure |
High risk |
5% dropouts |
Free of other bias? |
High risk |
Unit of randomization = episodes; patients to episodes ratio 0.89 |