A study in which two antibiotics (vancomycin and fidaxomicin) are compared in older patients with infections of the gut caused by bacteria called Clostridium difficile.
- Conditions
- Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)MedDRA version: 17.0Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-004619-31-IT
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 364
• Subject is 60 years of age or over.
• CDI is confirmed by clinical symptoms in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
• Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
• Subject agrees not to participate in another interventional study whilst participating in this 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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
• Subject is taking or requiring to be treated with prohibited medications
• Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
• Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
• Subject is unable to swallow oral study medication.
• Subject has a current diagnosis of toxic megacolon.
• Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
• Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
• Subject has previously participated in a CDI vaccine study
• Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
• Any clinical condition which, in the opinion of the Investigator, would not allow safe completion of this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method