| Methods |
Randomised controlled trial, double‐blinded |
| Participants |
Patients with neutropenia < 1000/mm3 anticipated to fall to 500/mm3 and fever ≥ 38.5 or > 38 in two measurements
Mean age 42(4‐78) with all types of cancer |
| Interventions |
Vancomycin
15 mg/kg x 2 versus placebo for persistent fever at 48‐60 hrs
Non‐intervention antibiotics: piperacillin‐tazobactam |
| Outcomes |
Failure
Mortality (all‐cause and infection‐related)
Superinfections
Adverse events |
| Notes |
First modification design
Multicentre ‐ Europe, Middle East, North America |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation. Randomisation was dynamically performed after the application of a randomisation algorithm, which used the minimisation technique of a global imbalances function between the 2 treatment arms, with the following 3 stratification variables: name and location of study centre, infection documentation at randomisation, and underlying disease |
| Allocation concealment (selection bias) |
Low risk |
Central randomisation |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
|
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patients included in mortality and failure analyses |
| Other bias |
Unclear risk |
Patients randomised only once |
