de Repentigny 1996.
Methods | A multicentre study at ten centres in Montreal, Canada, including university and private practice settings. Date of enrolment: No information provided. Loss to follow‐up: Ictraconazole ‐ 8/51 (16%) Ketoconazole ‐ 6/55 (9%) Analysis: no ITT; patients considered evaluable if they received at least 5 days consecutive days of treatment |
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Participants | Eligibility criteria: symptoms and signs of oropharyngeal and/or esophageal candidiasis as confirmed by microscopy and culture; 16 years and older; HIV positive Exclusion criteria: < 16 years old; pregnant or lactating; no effective contraceptive method; history of allergy to imidazole; concomitant treatment with rifampicin or antimycotic; received antifungal treatment in last 2 weeks for esophageal candidiasis; stomatitis and/or esophagitis secondary to herpetic infection; life expectancy less that 3 months; liver enzyme elevation (ALT and AST) > 500 IU/ml; unable or willing to give informed consent 106 patients enrolled with oropharyngeal candidiasis 51 ‐ Ictraconazole 55 ‐ Ketoconazole |
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Interventions | Ictraconazole: two 100mg capsules plus one ketoconazole placebo tablet daily Ketoconazole: one 200mg tablet plus two itraconazole placebo capsules daily Treatment duration: 2 weeks After completion of treatment patients who cleared were followed up for a period of 6 weeks |
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Outcomes | Clinical cure: Signs and symptoms were categorised as none (0), mild (1), moderate (2) or severe (3). Clinical cure defined as successful if signs + symptoms = 0 or failed if signs + symptoms > 0. Mycologic cure: successful if microscopy and culture negative for Candida. Relapse: clinical evidence of buccal candidiasis with mycological confirmation Adverse events: no significant differences between treatment groups. Common reported adverse events were nausea, headache, rash, diarrhoea and taste perversion. |
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Notes | Ethics: IRB of each centre approved study and informed consent obtained Study reports clinical cure at day 21 and not day 14. Mycologic cure reported for end of treatment (day 14). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomly assign to treatment in 1:1 ratio according to a computer generated schedule. |
Allocation concealment? | Unclear risk | Not reported |
Blinding? All outcomes | Unclear risk | Report the use of double blinding, however did not specify who was blinded. |
Incomplete outcome data addressed? All outcomes | Low risk | Reasons given for withdrawal given. |