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. 2010 Nov 10;2010(11):CD003940. doi: 10.1002/14651858.CD003940.pub3

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
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
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
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.
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).
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.