NCT01122368.

Methods	Phase two multicentre, randomized, parallel‐group study Duration of the study: 13 July 2010 to 15 December 2011 Patients excluded/patients randomized: 4/252 (1.6%) for mortality; 11/252 (4.4%) for IFI Sample size calculation/method description: Yes/No
Participants	Patients randomized: 252 Age: not reported (patients' characteristics originally reported in a summary table removed from the unpublished document on 25 April 2013) Sex: not reported Inclusion criteria: localized or generalized intra‐abdominal infection that required surgery and ICU stay Exclusion criteria: acute pancreatitis; neutropenia (< 1,000/mm3) at the time of randomization; infected intra‐peritoneal dialysis; patients undergoing solid organ transplantation, documented invasive candidiasis at the time of randomization, expected survival < 48 hours; any systemically active anti‐fungal within 14 days prior to administration of the study drug; allergy, hypersensitivity, or any serious reaction to an echinocandin anti‐fungal or any of the study drug excipients; received and/or had taken an investigational drug within 28 days prior to randomization; pregnant woman or breast‐feeding mother; ‘Do Not Resuscitate’ order, severe liver insufficiency, advanced liver fibrosis, cirrhosis or hepatitis. Percentage post‐surgical: 100% Percentage colonized with Candida at baseline: 27% (65/241) patients included in the Full analysis set
Interventions	1. Micafungin 100 mg/day (n = 122) 2. Placebo (n = 126) Duration of the intervention: Sufficient improvement of surgical condition as indicated by the recovery of GI function allowing introduction of enteral feeding of at least 50% of daily calorie requirement, confirmation of IFI, administration of alternative anti‐fungal therapy or death
Outcomes	Mortality Proven IFI Fungal colonization Follow‐up duration: until end of treatment
Type of antifungal treatment	Empiric
Funding sources	Astellas Pharma Inc.
Declaration of interest among the primary researchers	Not reported
Notes	Country: Europe (17 countries) Setting: multicentre study (53 centres) ICU
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: insufficient information to make a judgement about the randomization sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote: “Allocation: Randomized” (quoted from study protocol) Comment: insufficient information to make a judgement about concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “Masking : double blind (subject, caregiver, investigator, outcomes assessor)” (Quoted from study protocol)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “Masking : double blind (subject, caregiver, investigator, outcomes assessor)” (Quoted from study protocol)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: no clear reasons to exclude patients from “enrolled” group. No clear reasons related to the lack of reporting primary outcome for patients excluded from the safety analysis. Maybe the reasons were described in tables that had been removed from the reporting document on 25/04/2013
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available and all of the study prespecified (primary and secondary) outcomes were reported in the prespecified way
Other bias	Low risk	Comment: the study appeared free of other sources of bias