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)
Public ClinicalTrials.gov record NCT02218372. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02218372
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 148 participants
Conditions and interventions
Interventions
- Fidaxomicin oral suspension Drug
- Fidaxomicin tablets Drug
- Vancomycin oral liquid Drug
- Vancomycin capsules Drug
Drug
Eligibility (public fields only)
- Age range
- Up to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 9, 2015 (Actual)
- Primary completion
- Mar 7, 2018 (Actual)
- Completion
- Mar 7, 2018 (Actual)
- Last update posted
- Nov 26, 2024
2015 – 2018
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site US10015 | Orange | California | 92868 | — |
| Site US10010 | Chicago | Illinois | 60637 | — |
| Site US10004 | Indianapolis | Indiana | 46202 | — |
| Site US10025 | Louisville | Kentucky | 40202 | — |
| Site US10032 | Kansas City | Missouri | 64108 | — |
| Site US10030 | Omaha | Nebraska | 68114 | — |
| Site US10008 | Stony Brook | New York | 11794-8111 | — |
| Site US10028 | Chapel Hill | North Carolina | 27599 | — |
| Site US10027 | Cincinnati | Ohio | 45229-3039 | — |
| Site US10014 | Toledo | Ohio | 43606 | — |
| Site US10034 | Johnson City | Tennessee | 37604 | — |
| Site US10022 | Memphis | Tennessee | 38105-2794 | — |
| Site US10038 | Fort Worth | Texas | 76104 | — |
| Site US10037 | Salt Lake City | Utah | 84113 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02218372, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 26, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02218372 live on ClinicalTrials.gov.