Mondal 2004.

Methods	Single‐centre (India) double‐blind randomised trial conducted in a paediatric intensive care unit
Participants	Pediatric patients (1 month ‐ 12 years) with candidaemia
Interventions	Itraconazole versus fluconazole. Itraconazole (10mg/kg daily either orally or via gastric tube) or fluconazole (10mg/kg daily either orally or via gastric tube) were administered. The therapy was continued ≥1 wk after the blood culture become negative. Minimum duration of therapy was 2 weeks. Patients were followed for a median of 8 weeks
Outcomes	Primary endpoint: cure (treatment success) included both clinical and mycological endpoints. Clinical cure was defined as complete resolution of fever and improvement in signs and symptoms present at the time of enrolment. Mycological cure was defined as no growth of yeast in blood culture on two consecutive occasions 48 hrs apart Secondary endpoints: all‐cause mortality, IFI related mortality (candida‐attributable mortality was defined as death of a patient who had documented candidaemia (positive blood culture for Candida) within the previous 48 hrs), toxicities
Notes	Paediatric population only (range: 0 to 12 years). Authors contacted for further data (17/11/2008). Further data was received (11/12/2008). The study was conducted during an outbreak ofC. pelliculosa with 62% of cases caused by this unusual species.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Randomisation was achieved by using random tables.
Allocation concealment?	Low risk	A person not directly involved in the study made case allocation as per random number. The envelopes containing drug were stored with a member of staff who was responsible for case allocation.
Blinding? All outcomes	Low risk	Patients and investigators were blinded to the treatment administered.
Incomplete outcome data addressed? All outcomes	Low risk	Patients enrolled: 43 patients. Six patients received less than 1 week of therapy (3 patients each receiving itraconazole and fluconazole): Itraconazole; 1 patient died, two discontinued therapy. fluconazole; 2 patients died, one discontinued therapy.
Free of selective reporting?	Low risk	All expected outcomes are included in the report.
Free of other bias?	High risk	One potential bias given the small numbers in the study is the discontinuation of treatment due to social and financial reasons. Two patients receiving itraconazole, one patient receiving fluconazole and a further patient in whom the therapy is unclear left hospital due to financial and social reasons. Three patients discontinued all therapy (itraconazole; 2 patients, fluconazole; 1 patient) whereas the forth patients continued azole therapy at home.