Phase 2A study to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).

• Conditions: Clostridium difficile infections (CDI), also known as Clostridium difficile- associated diarrhea; MedDRA version: 17.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-001448-75-Outside-EU/EEA
• Lead Sponsor: Optimer Pharmaceutical, Inc. (a Cubist company)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-15
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Subjects with CDAD as defined by:
- Presence of either toxin A or B (or both) of C. difficile in the stool within 48 hours of enrolment, and
- Subjects 2 to less than 18 years: diarrhea defined as a change in bowel habits with >3 unformed bowel movements in the 24 hours prior to enrollment, and
- subjects 6 to less than 24 months: > 3 episodes of watery diarrhea in the 24 hours prior to enrolment

Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Subjects with severe complicated CDAD including fulminant colitis or inflammatory bowel disease (ulcerative colitis or Crohns’ disease)
- Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified