Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Public ClinicalTrials.gov record NCT03595553. 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, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.
Study identification
- NCT ID
- NCT03595553
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 759 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 28, 2019 (Actual)
- Primary completion
- Nov 17, 2021 (Actual)
- Completion
- Nov 17, 2021 (Actual)
- Last update posted
- Oct 9, 2026
2019 – 2021
United States locations
- U.S. sites
- 49
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | — |
| GI Alliance - Arizona Digestive Health - Sun City | Sun City | Arizona | 85351 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Paradigm Clinical Research Centers, Inc | Redding | California | 96601 | — |
| University Of California Davis | Sacramento | California | 95817 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| Alliance Medical Research LLC | Lighthouse PT | Florida | 33064 | — |
| Phoenix Medical Research LLC | Miami | Florida | 33165 | — |
| San Marcus Research | Miami Lakes | Florida | 33014 | — |
| Gasteroenterology Group of Naples | Naples | Florida | 31402 | — |
| HeuerMD Research Inc | Orlando | Florida | 32819 | — |
| Pines Care Research Center Inc. | Pembroke Pines | Florida | 33026 | — |
| Bardmoor Gastroenterology | Seminole | Florida | 33777 | — |
| Professional Health Care of Pinellas | St. Petersburg | Florida | 33713 | — |
| Florida Medical Clinic P.A. | Zephyrhills | Florida | 33542 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30333 | — |
| Grand Teton Research Group PLLC | Idaho Falls | Idaho | 83404 | — |
| GI Alliance - Illinois Gastro Group - Glenview | Glenview | Illinois | 60026 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| UnityPoint Health Peoria/Proctor | Peoria | Illinois | 61603 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| St. Vincent Hospital | Worcester | Massachusetts | 01608-1216 | — |
| Harper Hospital Department of Pharmacy Services | Detroit | Michigan | 48201-2020 | — |
| Detroit Receiving Hospital Department of Pharmacy Services | Detroit | Michigan | 48201 | — |
| Aa Mrc Llc | Flint | Michigan | 48504-4730 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073-6712 | — |
| Revival Research Institute, LLC. | Southfield | Michigan | 48034 | — |
| Mercury Street Medical Group PLLC | Butte | Montana | 59701 | — |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | — |
| New York Presbyterian Hospital Weill Cornell | New York | New York | 10021 | — |
| James J. Peters VAMC | The Bronx | New York | 10468 | — |
| ECU Adult Specialty Care | Greenville | North Carolina | 27834 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | — |
| Chattanooga Research and Medicine CHARM | Chattanooga | Tennessee | 37404-3230 | — |
| GI Alliance - Texas Digestive Disease Consultants - Arlington | Arlington | Texas | 76012 | — |
| GI Alliance - Texas Digestive Disease Consultants - Cedar Park | Cedar Park | Texas | 78613 | — |
| DM Clinical Research (Conroe Regional Hospital) | Conroe | Texas | 77304 | — |
| FMC Science | Lampasas | Texas | 76550 | — |
| GI Alliance - Texas Digestive Disease Consultants - San Marcos | San Marcos | Texas | 78666 | — |
| GI Alliance - Texas Digestive Disease Consultants - Webster | Webster | Texas | 77598 | — |
| Infectious Diseases Associates of Central VA | Lynchburg | Virginia | 24501 | — |
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 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03595553, 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 Oct 9, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03595553 live on ClinicalTrials.gov.