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. 2016 Jan 16;2016(1):CD004920. doi: 10.1002/14651858.CD004920.pub3

Eggimann 1999.

Methods Two‐centre, randomized, parallel group study
Duration of the study: the period was 30‐month long but the date were not reported
 Patients excluded/patients randomized: 6/49 (12%)
Sample size calculation/method description: Yes/Yes
Participants Patients randomized: 49
Age (median): 63 years (treatment group), 57 years (placebo group)
Sex: 28 male, 15 women
Inclusion criteria: recent abdominal surgery, recurrent gastrointestinal tract perforation, or anastomotic leakage
Exclusion criteria: documented or probable fungal infection requiring antifungal therapy, treatment with any investigational drug or with systemic antifungal drugs within 2 weeks of study entry, liver function tests that were at least five times the upper limit of normal, hepatic coma, renal failure requiring haemodialysis or peritoneal dialysis, or a high probability of death within 72 hours of study entry
 Percentage post‐surgical: 100%
 Percentage colonized with Candida at baseline: 40%
Interventions 1. Fluconazole 400 mg/day IV (n = 25)
 2. Placebo (n = 24)
Duration of the intervention: until complete resolution of intra‐abdominal disease
Outcomes Mortality
 Proven IFI
 Proven IFI with azole‐resistant species
 Fungal colonization
 Fungal colonization with azole‐resistant species
 Adverse events requiring cessation
Follow‐up duration: until one week post‐prophylaxis
Type of antifungal treatment Prophylaxis
Funding sources Quote: "Supported, in part, by a grant from Pfizer AG, Zurich, Switzerland. The funding agency did not participate in the collection or in the analysis of the data"
Declaration of interest among the primary researchers Not reported
Notes Country: Switzerland
 Setting: two hospitals, adult surgical/medical ICU
Other: the study was halted prematurely due to slow recruitment
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) Low risk Quote: "Each hospital pharmacy was provided with a randomization list established using randomly permuted blocks of ten, so as to allocate five patients to each regimen for every ten patients entered into the study"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Patients were randomized to receive fluconazole (400 mg once a day) or an identical‐appearing placebo (5% dextrose) administered intravenously for 30 minutes”
Comment: probably patients and personnel were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “To ensure the uniform recording of data, they were collected by a single person (P.E.) who was blinded as to study drug assignments. A five‐person monitoring committee, composed of three infectious disease specialists, a general surgeon, and a clinical microbiologist, performed blinded evaluation of each patient's eligibility, medical and surgical treatments, result of prophylaxis, cause of any infection, and cause of death”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: missing data outcome balanced across 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 report included all expected outcomes, including those that were prespecified
Other bias Low risk Comment: The study appeared free of other sources of bias