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

Astellas Pharma Europe Ltd.0 个研究点目标入组 250 人开始时间: 2010年1月28日最近更新: 2017年8月21日

试验速览

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•1.= 18 years of age.
•2.Localised or generalised Intra-abdominal infection requiring surgery and ICU stay.
•3.If CAI, duration of ICU stay of = 72 hrs (but not more than 120 hours), counted from the end of surgery, and a further expected duration of ICU stay of = 48 hours or more.
•4.If NAI, duration of ICU stay of = 48 hrs, counted from the end of surgery, and a further expected duration of ICU stay of = 48 hours or more.
•5.Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study. contraceptives, some IUDs, sexual abstinence or vasectomised partner.
•6.The subject has been fully informed and has given written informed consent to participate in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Acute pancreatitis.
•2.Neutropenia (ANC < 1,000/mm3) at the time of randomization.
•3.Infected intra-peritoneal dialysis.
•4.Patients undergoing solid organ transplantation.
•5.Documented invasive candidiasis at the time of randomization.
•6.Expected survival < 48 hours.
•7.Any systemically active anti-fungal administered within 14 days prior to administration of the study drug.
•8.Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients.
•9.Currently receiving and/or has taken an investigational drug within 28 days prior to randomization..
•10.Pregnant woman or breast-feeding mother.
•11.‘Do Not Resuscitate’ order.
•12.Severe liver insufficiency, advanced liver fibrosis, cirrhosis or hepatitis
•13.The subject, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol.
•14.Any concomitant medical condition that could interfere with the study conduct and protocol procedures or contraindicate subject’s participation in the study

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