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NCT03595553 · ClinicalTrials.gov registry record · Phase 3

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

A Phase 3 study of Clostridioides Difficile Infection, sponsored by Summit Therapeutics.

Completed
Registry status
Phase 3
Development phase
759
Enrollment target
20
Study locations

NCT03595553 is a Phase 3 study of Clostridioides Difficile Infection that has completed, run by Summit Therapeutics. The registered enrollment target is 759 participants, above the 299-participant average among 6 other Clostridioides Difficile Infection trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT03595553, a Phase 3 study of Clostridioides Difficile Infection, has completed, sponsored by Summit Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
759 participants
Enrollment target
20
Study locations

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

Clostridioides Difficile Infection

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

FieldValue
Enrollment Target 759 participants
Start Date 2019-01-28
Est. Completion 2021-11-17
Phase Phase 3

Sponsor

Summit Therapeutics

9 total trials

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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, categorized as Phase 3. The registered enrollment target is 759 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 299-participant average among 6 other Clostridioides Difficile Infection trials with a reported enrollment target (154% higher). The listed sponsor is Summit Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.

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.

NCT03595553 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Illinois.

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.

What interventions are being tested in trial NCT03595553?

The interventions under investigation include: Vancomycin (DRUG), Ridinilazole (DRUG).

Who is sponsoring clinical trial NCT03595553?

This trial is sponsored by Summit Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.