Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03595553

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection — Ri-CoDIFy 1  

Clostridioides Difficile Infection Clinical Trial

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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03595553
Study type Interventional
Source Summit Therapeutics
Contact
Status Completed
Phase Phase 3
Start date January 28, 2019
Completion date November 17, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03895593 - Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Withdrawn NCT04679324 - The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection
Completed NCT04675723 - The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
Recruiting NCT05693077 - Clostridioides Difficile Colonisation Phase 1
Completed NCT04668014 - The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection
Completed NCT03183141 - ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection Phase 3
Recruiting NCT05709184 - Lyophilized Fecal Microbiome Transfer vs. Vancomycin Monotherapy for Primary Clostridioides Difficile Infection N/A
Terminated NCT05526807 - Ursodeoxycholic Acid in C. Difficile Infection N/A
Recruiting NCT06306014 - Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients Phase 1/Phase 2
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Terminated NCT04802837 - Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects Phase 3
Active, not recruiting NCT04885946 - Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection N/A
Recruiting NCT04305769 - Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Phase 2
Recruiting NCT06106698 - Washed Microbiota Transplantation for Clostridioides Difficile Infection
Active, not recruiting NCT04781387 - Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection Phase 2
Completed NCT03595566 - To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT04725123 - Addressing Personalized Needs in Clostridioides Difficile Infection N/A
Not yet recruiting NCT05852587 - Xylitol Use for Decolonization of C. Difficile in Patients With IBD Phase 1
Completed NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 2
Recruiting NCT05612672 - Evaluation of GeoHAI Implementation N/A