EUCTR2014-003002-32-DE
Active, not recruiting
Phase 1
Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE
ConditionsClostridium 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]
DrugsDificlir
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
- Sponsor
- Astellas Pharma Europe Ltd.
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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