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 |
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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% |
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Interventions |
1. Fluconazole 400 mg/day IV (n = 25)
2. Placebo (n = 24) Duration of the intervention: until complete resolution of intra‐abdominal disease |
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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 |
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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 |
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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 |