To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 2)
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|ClinicalTrials.gov Identifier: NCT03595566|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : January 22, 2020
Summit is developing ridinilazole as a novel antimicrobial for Clostridium difficile Infection (CDI) 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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium 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 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|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||September 2021|
ridinilazole 200mg bid
|Active Comparator: vancomycin||
vancomycin 125mg 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 ]
- Sustained clinical response over 90 days [ Time Frame: Day 100 ]
- Incidence of treatment related adverse events as per CTCAE v4.0 [ Time Frame: From Day 1 to Day 100 (end of study) ]
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
|Contact: Lauren Kuhn||001 617 225 email@example.com|
|Contact: Winnie Barlow||01235 firstname.lastname@example.org|
|Study Director:||Richard Vickers, PhD||Summit (Oxford)Limited|