De Wit 1989.
Methods | Location of study: Belgium From November 1986 ‐ February 1988 patients presenting with severe oropharyngeal candidiasis were evaluated for the study. Follow‐up: one month. Loss to follow up: During treatment ‐ Fluconazole 1/18 (6%) Ketoconazole 3/19 (16%) During follow‐up ‐ Fluconazole 3 Ketoconazole 3 Analysis: no ITT |
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Participants | Eligibility criteria: AIDS/ARC patients, 18 years and older, severe oropharyngeal candidiasis confirmed by culture. Exclusion criteria: esophageal Candidiasis, other systemic antifungal drugs, known sensitivity to imidazoles, previous abnormalities of blood or urine chemistry after ketoconazole, impaired renal function, moderate to severe liver disease, drugs capable of inducing more rapid clearance of ketoconazole or that reduce / neutralise gastric acid. Diagnosis confirmed by culture 37 patients fluconazole ‐ 18 ketoconazole ‐ 19 |
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Interventions | 50mg fluconazole once daily 200mg ketoconazole once daily Treatment duration: 28 days |
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Outcomes | Clinical cure ‐ complete disappearance of mucosal lesions and symptoms Mycological cure ‐ culture assessments Relapses ‐ weekly clinical and mycological assessments for 4 weeks after treatment completion Adverse events: severe nausea in 1 fluconazole patient, transient rise ( < 3 times baseline) ALT or AST in 1 fluconazole and 4 ketoconazole patient |
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Notes | Ethics: nil reported | |
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 | Not reported |
Blinding? All outcomes | Unclear risk | Reported double blinding. Specified that participants were blinded. Unclear who else was blinded. |
Incomplete outcome data addressed? All outcomes | Unclear risk | Reasons given for those lost to follow‐up during treatment, not those lost during follow‐up period. |