Garbino 2002.

Methods	Monocentre, randomized, parallel‐group study Duration of the study: the period was 30 months but the dates were not reported Patients excluded/patients randomized: 16/220 (7%) Sample size calculation/method description: Yes/Yes
Participants	Patients randomized: 220 Age (mean): 52.9 years (treatment group), 55.9 years (placebo group) Sex: 140 men, 64 women Inclusion criteria: mechanical ventilation > 48 hours and expected further 72 hours and receiving selective digestive decontamination Exclusion criteria: life expectancy less than 7 days after randomization, history of systemic fungal infection, allergy to azoles, treatment with an antifungal agent seven days before randomization, blood culture positive for Candida spp. at study entry, acquired immunodeficiency syndrome, persistence of a prothrombin time less than 50% after 24 hours of administration of vitamin K (20 mg), neutropenia, pregnancy, anticipated duration of mechanical ventilation less than 72 hours at study entry, and refusal to give informed consent. Percentage post‐surgical: 60% Percentage colonized with Candida at baseline: 48%
Interventions	1. Fluconazole 100 mg/day IV (n = 110) 2. Placebo (n = 110) Duration of the intervention: until withdrawal from mechanical ventilation
Outcomes	Mortality Proven IFI 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: at least 30 days
Type of antifungal treatment	Prophylaxis
Funding sources	Quote: "The study was supported by an unrestricted grant by Pfizer Inc. Zurich, Switzerland"
Declaration of interest among the primary researchers	Not reported
Notes	Country: Switzerland Setting: single hospital, adult surgical/medical ICU
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Patients were randomly assigned… according to a list blinded to the study investigators and physicians in charge” Comment: insufficient information to make a judgement about random sequence generation
Allocation concealment (selection bias)	Low risk	Quote: “Patients were randomly assigned… according to a list blinded to the study investigators and physicians in charge”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “Patients were randomly assigned to receive PNV (polymyxin B (150 mg), neomycin (1000 mg), and vancomycin (1000 mg), in a 60 ml solution) plus intravenous fluconazole (100 mg in 50 ml NaCl 0.9%; n = 103) or PNV plus placebo (50 ml NaCl 0.9%; n = 101) according to a list blinded to the study investigators and physicians in charge”
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “Patients were randomly assigned… according to a list blinded to the study investigators and physicians in charge”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was not available but it was clear that the published reports included all expected outcomes
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias