Leon 1990.
Methods |
Duration of the intervention: 1 July 1987 to 1 August 1989 Patients excluded/patients randomized: 0/51 (0%) Sample size calculation/method description: No/No |
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Participants |
Patients randomized: 51 Age (mean): 62 years Sex: not reported Inclusion criteria: patients with severe infections treated with broad spectrum antibiotic therapy Exclusion criteria: not stated Percentage post‐surgical: 18% Percentage colonized with Candida at baseline: 50% |
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Interventions |
1. Amphotericin B orally 2 g daily (n = 24) 2. Placebo (n = 27) Duration of the intervention: not reported |
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Outcomes | Mortality Proven IFI Superficial fungal infection Follow‐up duration: until ICU discharge |
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Type of antifungal treatment | Empiric | |
Funding sources | Not reported | |
Declaration of interest among the primary researchers | Not reported | |
Notes |
Country: France Setting: single hospital, adult ICU |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: patients randomized according to a randomization table |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit a judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient information to permit a judgement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information about blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data outcome |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol was not available but it is clear that the published report included all expected outcomes |
Other bias | Low risk | Comment: the study appeared free of other sources of bias |