A study in which the blood levels of the antibiotic fidaxomicin are studied in patients with an inflammation of the intestine and concommitantly an infection of the gut caused by bacteria called Clostridium difficile.
- Conditions
- Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)MedDRA version: 18.0Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-003002-32-DE
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
? Subject is aged at least 18
? Confirmed diagnosis or history of IBD for at least 3 months
? CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrolment.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Subject is taking or requiring to be treated with prohibited medications
• Presence of an ostomy or short bowel syndrome
• Subject has a current diagnosis of toxic megacolon
• Subject has previously participated in a CDI vaccine study
• Subject has hypersensitivity to fidaxomicin or any of its components
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