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 Short-title: INTENSE - INTENSE

• Conditions: Invasive candidiasis; MedDRA version: 9.1Level: LLTClassification code 10007152; MedDRA version: 9.1Level: LLTClassification code 10007162

• Registration Number: EUCTR2008-006409-18-IT
• Lead Sponsor: ASTELLAS PHARMA EUROPE Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

1.≥ 18 years of age.
2.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. A highly effective method of birth control is defined as those which result in a low failure rate ( i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral 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. Witnessed informed consent is accepted in case the subject is capable of making the decision but not capable of signing the document. Subjects who lack the capacity to give consent may be included in the study with a relative/legal representative written agreement for the subject to participate according to the local law of the country. If during the course of the study drug treatment the subject condition changes and is capable of providing consent, then this will be obtained.
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.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.
13.The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, in the opinion of the Investigator, contraindicates their participation in this study.

Study & Design

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