Timsit 2012.

Trial name or title	Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi‐colonized With Candida, Randomized Controlled Trial (EMPIRICUS)
Methods	Two‐arm multicentre randomized controlled trial
Participants	Adult patients, mechanically ventilated for more than four days with sepsis of unknown origin and with at least one extra‐digestive fungal colonization site and multiple organ failure
Interventions	1) Micafungin 100 mg intravenously once a day for 14 days (empiric therapy) 2) placebo for 14 days
Outcomes	Primary outcomes: survival to 28 days without proven invasive infection; breakthrough infections occurring at least 48 hours after initiation of treatment Secondary outcomes: All‐cause mortality at 28 day and 90 days, antifungal‐free survival at 28‐days, organ failure, mechanical ventilation use, colonization index, serum biomarkers (1–3)‐β‐D‐glucan level, mannan antigenaemia, anti‐mannan antibodies, blood Candida PCR), incidence of ventilator‐associated bacterial pneumonia, pharmacokinetic/pharmacodynamic (PK/PD) profile of micafungin, tolerance of micafungin
Starting date	July 2012
Contact information	Jean‐François Timsit, University Grenoble 1, Intensive Care Unit, Albert Michallon Hospital, BP 217, 38043 Grenoble, Cedex 9, France
Notes	Target sample size: 260 patients

In the outcome section, we described the outcomes reported by the investigators.

ICU = intensive care unit

SOFA = sequential organ failure assessment score