Methods |
RCT
Double‐blind
1991‐1993 |
Participants |
Number: 411 patients (471 episodes)
Age: mean 48.5; range 17‐85 |
Interventions |
meropenem 1grx3
versus
ceftazidime 2grx3 |
Outcomes |
Overall and infection‐related mortality ‐ 7 days following end of treatment
Clinical failure
Treatment modifications
Superinfections
Adverse events |
Notes |
MC (US, Canada, Netherlands) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Patients were allocated at random for each neutropenic episode. Blinded drug was distributed based on a schedule that provided a stratified, balanced, block random assignment within each center, stratification was by the presence or absence of prophylactic treatment with antiviral medication. As patients were enrolled for specific neutropenic episodes, they were assigned the next available number and associated randomized treatment |
Allocation concealment? |
Unclear risk |
No description |
Blinding?
All outcomes |
Low risk |
Double‐blind |
Incomplete outcome data addressed?
All‐cause mortality |
High risk |
2% dropouts |
Incomplete outcome data addressed?
Treatment failure |
High risk |
Number of dropouts (13%) known per study group |
Free of other bias? |
High risk |
Unit of randomization = episodes; patients to episodes ratio 0.87 |