Wingard 2010.
Study characteristics | ||
Methods | Randomization in a 1:1 ratio in permuted blocks (size not stated). | |
Participants | 600 patients with leukaemia or other haematopoietic disorders receiving allogeneic haematopoietic stem cell transplantation treated prophylactically with either voriconazole or fluconazole. |
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Interventions | Voriconazole: 200 mg orally twice daily for 100 days. Fluconazole 400 mg once daily for 100 days. |
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Outcomes | Primary outcome: Fungal free survival at 180 days Secondary outcomes: incidence of invasive fungal infections. Time to invasive fungal infections. Six month and 1 year relapse free survival. Overall survival. Time to and duration of empiric antifungal therapy. Frequency of adverse events. Incidence of acute or chronic graft‐versus‐host disease |
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Notes | The follow‐up period was 180 days and 1 year Supported by a grant from the National Institutes of Health and an "unrestricted educational grant" from Pfizer |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | 1:1 permutated blocks, unclear if allocation concealment was obtained |
Blinding (performance bias and detection bias) All outcomes | Low risk | The clinician, patient and the data review board were blinded |