Micafungin
DrugIV
Other names: FK463, mycamine
NCT Number: NCT01122368
Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Innsbruck, Austria
Subjects will be assessed at the following visits:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV
Other names: FK463, mycamine
IV
Time frame: During treatment
Time frame: Baseline to End of Treatment visit
Time frame: At the EOT visit
Time frame: At the EOT visit
Time frame: At the EOT visit
Time frame: At the End of Study visit
Time frame: From Day 1 until 28 days after end of study drug treatment
Time frame: From Day 1 until 28 days after end of study drug treatment
Time frame: From Day 1 until 28 days after end of study drug treatment
Time frame: At the End of Study and Long-Term Follow Up visit
Time frame: At the End of Study visit
Time frame: At the End of Study visit
Astellas Pharma Inc
Industry
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 - A Multicentre, Randomized, Double-blind Study
Acronym: INTENSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04368559
Aspergillus, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT04157465
Acute-On-Chronic Liver Failure, Antifungal Agents
Chandigarh, Uttarakhand, India
View Trial DetailsNCT01058174
Bacterial Infections and Mycoses, Infections
Innsbruck, Austria
View Trial DetailsNCT03667690
Bacterial Infections and Mycoses, Candidemia
Birmingham, Alabama, United States
View Trial Details