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Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
NCT03595553 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Vancomycin
- DRUG Ridinilazole
Study Locations (20)
Florida
- Midway Immunology and Research Center — Ft. Pierce
- Alliance Medical Research LLC — Lighthouse PT
- Phoenix Medical Research LLC — Miami
- San Marcus Research — Miami Lakes
- Gasteroenterology Group of Naples — Naples
- HeuerMD Research Inc — Orlando
- Pines Care Research Center Inc. — Pembroke Pines
- Bardmoor Gastroenterology — Seminole
- Professional Health Care of Pinellas — St. Petersburg
- Florida Medical Clinic P.A. — Zephyrhills
California
- David Geffen School of Medicine at UCLA — Los Angeles
- Facey Medical Foundation — Mission Hills
- Paradigm Clinical Research Centers, Inc — Redding
- University Of California Davis — Sacramento
Illinois
- GI Alliance - Illinois Gastro Group - Glenview — Glenview
- Loyola University Medical Center — Maywood
Alabama
- University of Alabama - Birmingham — Birmingham
Arizona
- GI Alliance - Arizona Digestive Health - Sun City — Sun City
Georgia
- Infectious Disease Specialists of Atlanta — Decatur
Idaho
- Grand Teton Research Group PLLC — Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2021-11-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03595553
The ClinicalTrials.gov registry entry for NCT03595553 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 759 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Summit Therapeutics, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Clostridioides Difficile Infection appearing as the primary indexed condition, and to 2 interventions — of which Vancomycin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03595553 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03595553 about?
NCT03595553 is a clinical study titled "Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection". 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 treate...
What is the current status of trial NCT03595553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 759 participants. The study started on 2019-01-28. Estimated completion is 2021-11-17.
What conditions does trial NCT03595553 study?
This clinical trial studies the following conditions: Clostridioides Difficile Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03595553?
The interventions under investigation include: Vancomycin (DRUG), Ridinilazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03595553?
This trial is sponsored by Summit Therapeutics, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03595553 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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