Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)
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|ClinicalTrials.gov Identifier: NCT03595553|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : April 9, 2021
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.
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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridioides Difficile Infection||Drug: ridinilazole Drug: vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||680 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 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|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||September 2021|
ridinilazole (200 mg bid)
|Active Comparator: vancomycin||
vancomycin (125 mg qid)
- Sustained clinical response defined as clinical cure at the Assessment of Cure (AOC) visit and no recurrence of CDI within 30 days post end of treatment (EOT) [ Time Frame: Day 40 ]
- Clinical cure at Assessment of Cure (AOC) visit [ Time Frame: Day 12 ]
- Sustained clinical response over 60 days [ Time Frame: Day 70 ]defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT
- Sustained clinical response over 90 days [ Time Frame: Day 100 ]defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT
- Investigator assessment of clinical cure at the AOC visit [ Time Frame: Day 12 ]
- Investigator assessment of sustained clinical response at 30, 60- and 90-days post EOT [ Time Frame: Days 40, 70 and 100 ]
- Relative abundance and diversity of the microbiome and bile salt composition in fecal samples at the end of treatment [ Time Frame: Day 1 to Day 40 ]
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): NCT03595553
|Contact: Mary Alvarado||+1 617 401 firstname.lastname@example.org|
|Study Director:||Jos Houbiers, MD, PhD||Summit Therapeutics|