Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Ri-CoDIFy 3)
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|ClinicalTrials.gov Identifier: NCT04802837|
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : May 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Clostridioides Difficile Infection||Drug: Ridinilazole Drug: Vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole 200mg dosed BID for 10 days.
Active Comparator: Vancomycin
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin 125mg dosed QID for 10 days.
- Incidence and severity of treatment emergent adverse events [ Time Frame: Day 1 through Study Completion, an average of 100 days ]
- Plasma concentration of ridinilazole [ Time Frame: Day 1 ]
- Plasma concentration of ridinilazole [ Time Frame: Day 5 ]
- Fecal concentration of ridinilazole [ Time Frame: Day 1 ]
- Fecal concentration of ridinilazole [ Time Frame: Day 5 ]
- Sustained clinical response (SCR) over 30 days post end of treatment (EOT) - defined as clinical cure at the assessment of cure (AOC) visit and no recurrence of CDI within 30 days post EOT [ Time Frame: 30 days post EOT ]
- Clinical cure at the assessment of cure (AOC) visit [ Time Frame: Day 12 ]
- Sustained clinical response over 60 days post EOT [ Time Frame: 60 days post EOT ]
- Sustained clinical response over 90 days post EOT [ Time Frame: 90 days post EOT ]
- SCR based on clinical response - defined as clinical response with no recurrence assessed through 30 days post-EOT [ Time Frame: 30 days post EOT ]
- Clinical response at the AOC visit [ Time Frame: Day 12 ]
- Medical resource utilization and health economics endpoints [ Time Frame: Day 1 through Study Completion, an average of 100 days ]Data will include length of hospital stay, hospital admission and readmission rates and reasons for admission, subject location at admission and subject's discharge location, other location of healthcare access that didn't result in hospitalization i.e. urgent care facility, doctor visit, telemedicine.
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): NCT04802837
|Contact: Sr. Director, Medical Information||+1 833 256 email@example.com|
|Study Director:||Lori Styles, MD||Summit Therapeutics|