To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03595566|
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : October 13, 2022
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridioides Difficile Infection||Drug: ridinilazole Drug: vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||In both arms patients receive the same number of doses per day. Placebo tablets are included to maintain the same number and appearance of IP in both arms.|
|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)|
|Actual Study Start Date :||January 28, 2019|
|Actual Primary Completion Date :||November 19, 2021|
|Actual Study Completion Date :||November 19, 2021|
ridinilazole 200mg bid
|Active Comparator: vancomycin||
vancomycin 125mg qid
- Sustained Clinical Response (SCR) defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). [ Time Frame: Day 40 ]
- Clinical Response [ Time Frame: Day 12 ]
less than 3 unformed bowel movements (UBMs) for 2 consecutive days and maintained through EOT without further CDI treatment at EOT + 2 days, or
the investigator's assessment that the subject no longer needs specific CDI antimicrobial treatment after completion of the course of study medication.
- Clinical Cure [ Time Frame: Day 12 ]defined as the resolution of diarrhea (<3 UBMs in the 1-day period immediately prior to EOT, that is maintained for 2 days after EOT).
- Sustained Clinical Response over 60 days [ Time Frame: Day 70 ]defined as Clinical Response and no recurrence of CDI through 60 days post EOT
- Sustained Clinical Response over 90 days [ Time Frame: Day 100 ]defined as Clinical Response and no recurrence of CDI through 90 days post EOT
- Change from baseline to EOT of the relative abundance of the 3 main bile acid groups (conjugated primary, primary and secondary bile acids) [ Time Frame: Day 10 ]
- Change from baseline to EOT of the microbiota α-diversity (Shannon) index in stool samples [ Time Frame: Day 10 ]
- Change from baseline to EOT of the gut microbiota β-diversity (Bray-Curtis) index in stool samples [ Time Frame: Day 10 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595566
|Study Director:||Lori Styles, MD||Summit Therapeutics|