Phase 3
N=237
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Clostridium Infections · Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00269399 ↗Enrolled (actual)
237
Serious AEs
17.8%
Results posted
Oct 2019
Primary outcome: Primary: Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea. — 67; 73 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Xifaxan) (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea. |
67; 73 | — |
| SECONDARY Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success |
61; 63 | — |
Summary
The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort.
- Subject has a positive Clostridium difficile stool toxin assay at screening
Exclusion Criteria
- Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months.
- Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS])
- Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization.
Data sourced from ClinicalTrials.gov (NCT00269399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.