Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
Public ClinicalTrials.gov record NCT04781387. 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 2, Randomized, Double-Blind, Comparator-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CRS3123 Compared With Oral Vancomycin in Adults With Clostridioides Difficile Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults \> or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.
Study identification
- NCT ID
- NCT04781387
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 5, 2021 (Actual)
- Primary completion
- Apr 16, 2024 (Actual)
- Completion
- Apr 16, 2024 (Actual)
- Last update posted
- Mar 27, 2026
2021 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 131 | Fullerton | California | 92835 | — |
| 117 | Lancaster | California | 93534 | — |
| 143 | Mission Hills | California | 91345 | — |
| 138 | Orange | California | 92868 | — |
| 146 | Miami | Florida | 33125 | — |
| 122 | Miami | Florida | 33144 | — |
| 140 | Marietta | Georgia | 30060 | — |
| 110 | Idaho Falls | Idaho | 83404 | — |
| 129 | Winfield | Illinois | 60190 | — |
| 130 | Royal Oak | Michigan | 48073 | — |
| 139 | Weldon Spring | Missouri | 63304 | — |
| 128 | Butte | Montana | 59701 | — |
| 134 | The Bronx | New York | 10467 | — |
| 147 | Chapel Hill | North Carolina | 27514 | — |
| 114 | Uniontown | Pennsylvania | 15401 | — |
| 104 | Cedar Park | Texas | 78613 | — |
| 123 | Houston | Texas | 77079 | — |
| 101 | San Antonio | Texas | 78229 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04781387, 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 Mar 27, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04781387 live on ClinicalTrials.gov.