De Wit 1997.
Methods | Multicenter, multi‐country study ‐ 4 hospitals: Brussels; London; Manchester; Paris Dates of enrolment and/or randomisation not reported. Loss to follow‐up: D1 ‐ 3/13 (23%) D2 ‐ 0/14 (0%) Analysis: no ITT |
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Participants | Eligibility criteria: HIV positive, age 18‐62 years, patients who had oro‐pharyngeal with or without esophageal candidiasis Exclusion criteria: History of clinical failure of fluconazole, abnormal ECG, concomitant medication with agents known to induce cytochrome P450 or to interact with azoles, history of intolerance to azoles, acute or chronic liver disease. Diagnosis confirmed by colony forming units on culture 27 patients enrolled D1= 13 D2= 14 |
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Interventions | D1 ‐ D0870 100mg initial dose followed by 25 mg/day for 4 days D2 ‐ D0870 10mg once daily for 5 days | |
Outcomes | Clinical response was recorded as cleared, improved, failure or not evaluable. Relapse: Patients were assessed 7 and 14 days after end of treatment for evaluation of relapses. Adverse events: 1 patients experienced dizziness (D1) and another had diarrhoea (D2). |
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Notes | Ethics: IRB of each centre approved protocol and informed consent obtained | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Method of allocation sequence generation not specified. |
Allocation concealment? | Unclear risk | "..sealed envelopes detailing the allocation randomised treatment" |
Blinding? All outcomes | Unclear risk | Reported double blinding. Specified that participants were blinded. Unclear who else was blinded. |
Incomplete outcome data addressed? All outcomes | Low risk | Reasons for lost to follow‐up given |