A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Va… (NCT02218372) | Clinical Trial Compass
CompletedPhase 3
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)
United States148 participantsStarted 2015-01-09
Plain-language summary
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.
Who can participate
Age range17 Years
SexALL
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Inclusion Criteria:
* 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 des…
What they're measuring
1
Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days