A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Completed · Phase 3
Conditions studied: Clostridium Difficile-associated Diarrhea (CDAD)
In brief
The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.
Key facts
- Study ID
- NCT02218372
- Run by
- Astellas Pharma Europe B.V.
- People needed
- 148
- Starts
- 2015-01-09
- Expected to finish
- 2018-03-07
- Last updated by the study team
- 2024-11-26
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:
- Subject from Birth to < 2 years: watery diarrhea in the 24 hours prior to screening.
- Subject ≥ 2 years to < 18 years: ≥ 3 unformed bowel movements in the 24 hours prior to screening.
- Male and female subjects aged from birth to < 18 years: Note that in the United States of America subjects can only be included if aged ≥ 6 months to < 18 years.
- For subjects < 5 years: Negative rotavirus test.
- Female subject of childbearing potential:
- must have a negative urine pregnancy test at Screening, and
- must abstain from sexual activity for the duration of the study, or
- must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while in the study (with the exception of studies as described in exclusion criteria below).
You may not qualify if…
- Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD. If the investigator feels the clinical imperative is to begin treatment before knowing the laboratory result for toxigenic C. difficile, up to four doses but no more than 24 hours of treatment with metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
- Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
- Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease etc.).
- Subject has diarrhea caused by an agent other than C. difficile (e.g. infections, infestations, drugs etc.).
- Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
- Subject has received an investigational therapy within 28 days, prior to Screening, with the exception of studies with primary treatment for cancer without novel Investigational Medicinal Product (IMP) and which do not affect the assessment of diarrhea.
Where it is running
- Site US10015 — Orange, California, United States
- Site US10010 — Chicago, Illinois, United States
- Site US10004 — Indianapolis, Indiana, United States
- Site US10025 — Louisville, Kentucky, United States
- Site US10032 — Kansas City, Missouri, United States
- Site US10030 — Omaha, Nebraska, United States
- Site US10008 — Stony Brook, New York, United States
- Site US10028 — Chapel Hill, North Carolina, United States
- Site US10027 — Cincinnati, Ohio, United States
- Site US10014 — Toledo, Ohio, United States
- Site US10034 — Johnson City, Tennessee, United States
- Site US10022 — Memphis, Tennessee, United States
- Site US10038 — Fort Worth, Texas, United States
- Site US10037 — Salt Lake City, Utah, United States
- Site BE32001 — Brussels, Flemish Brabant, Belgium
- Site BE32003 — Ghent, Belgium
- Site BE32002 — Liège, Belgium
- Site CA15003 — Oshawa, Ontario, Canada
- Site FR33002 — La Tronche, France
- Site FR33001 — Nice, France
- Site FR33007 — Nice, France
- Site FR33005 — Paris, France
- Site FR33008 — Strasbourg, France
- Site DE49010 — Essen, Germany
- Site DE49002 — Frankfurt Am M., Germany
Full record on ClinicalTrials.gov
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