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
- Conditions
- Invasive Candidiasis caused by intra-abdominal infectionsfungal infections that entered your body10017528
- Registration Number
- NL-OMON34416
- Lead Sponsor
- Astellas Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
The subject will be eligible for the study if all of the following apply:
1. >= 18 years of age.
2. Localized or generalized intra-abdominal infection requiring surgery and ICU stay.
3. If CAI, at least 72 hours (but not more than 120 hours) of ICU stay, counted from the end of surgery, and a further expected duration of ICU stay of >= 48 hours.
4. If NAI, duration of ICU stay <= 48 hours, counted from the end of surgery, and a further expected duration of ICU stay of >= 48 hours.
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.
Subjects will be excluded from participation if any of the following apply:
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary parameters:<br /><br>- The incidence of an invasive fungal infection<br /><br>- The time to develop an invasive fungal infection. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br>To assess the efficacy, organ dysfunction, safety and tolerability, survival<br /><br>and health economic variables in subjects treated pre-emptively with Micafungin<br /><br>versus placebo.</p><br>