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: 17.1Level: 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-DE
- 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 prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). Patients unable to provide informed consent may be included into the study after the approval of their legal guardian by written informed consent, only.
• 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.
•Subject currently has diagnosed inflammatory bowel disease (IBD)
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