Hernandez 1994.

Methods	Open multicentre study in Spain with patients enrolled from January to July 1992. 4 week follow‐up Loss to follow‐up: Ketoconazole ‐ 1/22 (5%) Fluconazole ‐ 0/24 (0%) Analysis: no ITT
Participants	Eligibility: HIV patients randomised, able to swallow medication, age between 7 weeks to 14 years, had clinical signs and symptoms of oropharyngeal candidiasis and positive findings on microscopy pending confirmation by culture Exclusion criteria: Positive pregnancy test, Mycoses other than oropharyngeal candidiasis, life expectancy < 4 weeks Diagnosis confirmed using microscopy and culture 46 patients randomised enroled 24 fluconazole 22 ketoconazole
Interventions	Fluconazole oral suspension once daily in a dose of 3mg/kg body weight for 23/24 patients randomised and 2mg/kg body weight in 1/24 patients randomised. Mean treatment duration 14 days (range 6‐33days) Ketaconazole oral suspension: once daily in a dose of 7mg/kg body weight in 19/22 patients randomised and 3,5mg/kg body weight in 3/22 patients. Mean treatment duration 16 days (range 5‐49days)
Outcomes	Clinical response: Clinical cure ‐ resolution pretreatment signs and symptoms Clinical improvement ‐ partial resolution pre‐treatment signs and symptoms Clinical failure ‐ no change / worsening Relapse ‐ initial improvement or resolution of signs and symptoms followed by worsening or reappearance. Mycological response: Cure ‐ complete eradication Candida + clinical cure Colonization ‐ positive culture and absence of clinical disease Failure ‐ positive culture and presence clinical disease Reinfection ‐ reappearance of Candida Adverse events : GIT toxicity ‐ 1 patient ketoconazole group (diarrhoea and abdominal pain). Two patients also had increased ALT and AST vs 1 in fluconazole. 1 in latter group also had thrombocytopaenia
Notes	Ethics: legal guardian / parents informed consent obtained. Patients in 2 groups were given different doses
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method not specified
Allocation concealment?	High risk	"open study"
Blinding? All outcomes	High risk	No blinding
Incomplete outcome data addressed? All outcomes	Low risk	Loss to follow‐up less than 10%