Slotman 1987.

Methods	Monocentre, randomized, parallel‐group study Duration of the study: not reported Patients excluded/patients randomized: 17/74 (23%) Sample size calculation/method description: No/No
Participants	Patients randomized: 74 Age (mean): 65 years (treatment group), 59 years (placebo group) Sex: not reported Inclusion criteria: adult patients without fungal colonization and with three or more risk factors for fungal infection (age greater than 40 years, second‐ and third‐degree burns covering greater than 30% of body surface area, antibiotics greater than seven days, three or more antibiotics, severe sepsis unresponsive to antibiotics, diabetes, steroids greater than seven days, acute renal failure, immunosuppressive therapy or chemotherapy, advanced malignancy, total parenteral nutrition, multi trauma, serum glucose greater than 11.1 mmol/L, intra‐abdominal abscess, peritonitis, or severe head injury) Exclusion criteria: pregnant patients, patients with sensitivity to ketoconazole, or any of the imidazole derivatives, patients with a previous or current history of hepatic cirrhosis, or acute hepatic failure Percentage post‐surgical: 97% Percentage colonized with Candida at baseline: 20%
Interventions	1. Ketoconazole 200 mg/day orally (n = 27) 2. Placebo (n = 30) Duration of the intervention: until ICU discharge
Outcomes	Mortality Proven IFI Proven IFI with azole‐resistant Candida species Fungal colonization Fungal colonization with azole‐resistant Candida species Follow‐up duration: until ICU discharge
Type of antifungal treatment	Prophylaxis
Funding sources	Quote: "Grant Support by Janssen Pharmaceutica, New Brunswick, NJ."
Declaration of interest among the primary researchers	Not reported
Notes	Country: USA Setting: single hospital, adult surgical ICU Other: Patients colonized with Candida at baseline excluded from the analysis
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	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	Quote: "Randomized patients who were found subsequently to have been colonized with fungi within 24 hours of entry into the study were considered precolonized and were excluded retrospectively" Comment: prespecified reason for excluding patients from the analysis
Selective reporting (reporting bias)	Low risk	The study protocol was not available but it was clear that published report included all expected outcomes
Other bias	Low risk	Comment: the study appears to be free of other sources of bias