EUCTR2008-006409-18-GRActive, not recruitingPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Astellas Pharma Europe Ltd.
- Enrollment
- 250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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