A Phase 2, Randomized, Double-Blind, Comparator-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CRS3123 Compared With Oral Vancomycin in Adults With Clostridioides Difficile Infection
Overview
- Phase
- Phase 2
- Intervention
- CRS3123
- Conditions
- Clostridioides Difficile Infection
- Sponsor
- Crestone, Inc
- Enrollment
- 43
- Locations
- 20
- Primary Endpoint
- Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CRS3123 200 milligram
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 6-hour intervals for 10 days. Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
Intervention: CRS3123
CRS3123 400 milligram
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 6-hour intervals for 10 days. Due to the difference in dosing schedules between CRS3123 (twice a day) and the standard of care vancomycin (four times a day) and appearance of study drugs used in the 3 Arms, placebo will be used to match the total number of capsules in each arm.
Intervention: CRS3123
Vancomycin 125 milligram
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
Intervention: Active Comparator
Outcomes
Primary Outcomes
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
Time Frame: TOC/Day 12
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day 12 visit.
Secondary Outcomes
- Rate of Clinical Cure at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(TOC/Day 12)
- Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(TOC/Day 12)
- Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(TOC/Day 12)
- Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(TOC/Day 12)
- Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Microbiological-ITT (mITT) Population(Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12)
- Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12)
- Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiologically Evaluable (ME) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Global Cure in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 40)
- Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiological-ITT (mITT) Population(Day 40 - Day 70)
- Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiologically Evaluable (ME) Population(Day 40 - Day 70)
- Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiological-ITT (mITT) Population(Post TOC/Day 12 visit through Day 70)
- Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiologic Evaluable (ME) Population(Post TOC/Day 12 visit through Day 70)
- Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations(Post TOC/Day 12 visit through Day 40)