WHO ICTRP trial

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a…

NL-OMON34416 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting

Key facts

Trial ID NL-OMON34416
Public title An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis versus Placebo in High Risk Surgical Subjects with Intra-abdominal Infections - A Multicentre, Randomized, Double-Blind Study
Scientific title An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis versus Placebo in High Risk Surgical Subjects with Intra-abdominal Infections - A Multicentre, Randomized, Double-Blind Study - INTENSE
Primary sponsor Astellas Pharma B.V.
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Not Recruiting
Study type Interventional
Phase 2
Countries Austria;Belgium;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Norway;Poland;Romania;Russian Federation ;Spain;Switzerland;Turkey;United Kingdom
Conditions Invasive Candidiasis caused by intra-abdominal infections; fungal infections that entered your body;10017528;Invasive Candidiasis caused by intra-abdominal infections; fungal infections that entered your body
Interventions The subjects will be entered into the study for 4 months. All participants will start with the pre-emptive treatment (Mycamine or placebo) for their condition for at least 1 day and a maximum of 6 weeks. The subject will receive the study…
Registration date Mar 1, 2011
Target size 20
Secondary IDs 2008-006409-18;NCT01122368;NL33282.056.10
Registry page onderzoekmetmensen.nl

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