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 28, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | June 11, 2018 | ||||
First Posted Date ICMJE | July 23, 2018 | ||||
Last Update Posted Date | January 28, 2021 | ||||
Actual Study Start Date ICMJE | January 28, 2019 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | Summit is developing ridinilazole as a novel antimicrobial for Clostridium 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized 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. Primary Purpose: Treatment
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Condition ICMJE | Clostridioides Difficile Infection | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Carlson TJ, Endres BT, Bassères E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26. Review. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
680 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2021 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria Patients are eligible to be included in the study only if all the following criteria apply:
Exclusion Criteria Patients are excluded from the study if any of the following criteria apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belarus, Belgium, Canada, Chile, Czechia, Estonia, France, Georgia, Germany, Israel, Latvia, Lithuania, Mexico, Peru, Romania, Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03595566 | ||||
Other Study ID Numbers ICMJE | SMT19969/C005 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Summit Therapeutics | ||||
Study Sponsor ICMJE | Summit Therapeutics | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Summit Therapeutics | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |