De Wit 1998.
Methods | A single‐centre study done at the reference hospital of Saint Pierre, Brussels, Belsgium Loss to follow‐up: Fluconazole ‐ 0/20 (0%) Ictraconazole ‐ 3/20 (15%) Analysis: no ITT No dates for start or end of study reported. |
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Participants | Inclusion criteria: 16‐65 years; AIDS / AIDS‐related complex, who are able to take oral medication; OPC suspected on clinical grounds Exclusion criteria: received antifungal treatment within 1 week before enrolment; or maintenance azole treatment for prevention of OPC during previous month; hepatic or renal disease; allergy to azole compounds or if they had had more than three OPC episodes during previous 2 months; end stage AIDS; fever of unknown origin; documented systemic fungal infections; any other acute concomitant infection; pregnancy and lactation. 40 enrolled Fluconazole =20 Ictraconazole = 20 diagnosis confirmed KOH and culture |
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Interventions | Fluconazole ‐ 150 mg stat Intraconazole ‐ 100 mg daily for 7 days | |
Outcomes | Clinical Cure : Signs and symptoms of OPC were graded on scale from 0 (absent) to 3 (severe). Symptoms and signs included soreness, burning or pain, dysphagia, erythema, and presence of white plaques. Extent of lesions present was graded on a scale of 0 (no lesions) to 4 (lesions covering more than 70% of oral mucosa). These scores were combined to give an overall clinical score. Clinical cure was defined as disappearance of all symptoms (clinical score = 0), improvement defined as clinical score lower than baseline score and failure as no change in clinical score or worsening of clinical symptoms. Relapse: defined as initial improvement or cure followed by reappearance of symptoms within 30 days after baseline examination. Mycological evaluation: eradication was defined as recovery of less than 10 colony forming units (CFUs)/ml, improvement as a count below baseline count but above 10 CFUs/ml and failure as an increase or no change. Adverse events: none reported |
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Notes | Ethics: Written informed consent obtained | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Method not specified |
Allocation concealment? | Unclear risk | Not reported |
Blinding? All outcomes | High risk | No blinding |
Incomplete outcome data addressed? All outcomes | Low risk | 3/20 lost to follow‐up in itraconazole group ‐ reasons provided. |