Ables 2000.

Methods	Multicentre, randomized, parallel‐group study Duration of the study: October 1994 to December 1996 Patients excluded/patients randomized: 6/125 (5%) Sample size calculation/method description: No/No
Participants	Patients randomized: 125 Age (mean): 46 years (treatment group), 42 years (placebo group) Sex: 82 men, 37 women Inclusion criteria: trauma or surgical patients, expected length of stay > 48 hours, > 1 risk factors (e.g. central venous line, total parenteral nutrition, mechanical ventilation, antibiotics administration, etc.) Exclusion criteria: unexpected serious adverse reaction to azole drugs, thrombocytopenia (< 5000/mm3), leucopenia (< 4000/mm3), increasing liver function tests greater than five times the upper limits of normal, pregnancy, anticipated life expectancy of less than three months, severe liver disease, current treatment with a systemic antifungal agent Percentage post‐surgical: > 30% Percentage colonized with Candida at baseline: 24%
Interventions	1. Fluconazole 800 mg/day IV initially then 400 mg/day IV or orally (n = 63) 2. Placebo (n = 62) Duration of the intervention: until ICU discharge
Outcomes	Mortality Proven IFI Suspected IFI Proven or suspected IFI Proven IFI with azole‐resistant species Superficial FI Fungal colonization Fungal colonization with azole‐resistant species Adverse events requiring cessation Follow‐up duration: until hospital discharge
Type of antifungal treatment	Prophylaxis
Funding sources	Quote: "This study was supported by an investigator‐initiated grant from Roerig/Pfizer"
Declaration of interest among the primary researchers	Not reported
Notes	Country: USA Setting: single hospital, adult ICU
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Patients meeting the eligibility criteria were randomly assigned to receive one of the following two prophylaxis regimen…” Comment: insufficient information to make a judgement
Allocation concealment (selection bias)	Unclear risk	Comment: insufficient information to make a judgement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: insufficient information to make a judgement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: insufficient information to make a judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: missing outcome data balanced in numbers across groups, and reasons for missing outcome data unlikely to be related to true outcome
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was not available, but it was clear that the published report included all expected outcomes
Other bias	Low risk	The study appeared free of other sources of bias