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

• Conditions: Invasive Candidiasis; MedDRA version: 13.1Level: LLTClassification code 10007162Term: Candidiasis of the intestineSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10007152Term: CandidiasisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2008-006409-18-DK
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-27
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified