Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Drug: Active Comparator
- Registration Number
- NCT04781387
- Lead Sponsor
- Crestone, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin 125 milligram Active Comparator Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days. CRS3123 400 milligram CRS3123 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. CRS3123 200 milligram CRS3123 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.
- Primary Outcome Measures
Name Time Method Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population Last dose plus two days
- Secondary Outcome Measures
Name Time Method Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations TOC - Day 40 Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations Last dose plus two days Rate of late recurrence of Clostridioides difficile infection (between Day 40 and Day 70) in the Micro-Intent to Treat and Microbiologically Evaluable populations Day 40 - Day 70 Rate of clinical cure at TOC as assessed by the investigator in the ITT, Micro-ITT, PP, and ME populations Last dose plus two days Rate of total relief of symptoms of Clostridioides difficile infection at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations Last dose plus two days Time to resolution of diarrhea through Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations Randomization until the date of documented resolution, assessed up to 2 days after the last dose of study treatment (TOC) Rate of early recurrence of Clostridioides difficile infection through Day 40 in the Micro-ITT and ME populations TOC - Day 40 Rate of recurrence of Clostridioides difficile infection through Day 70 in the Micro-Intent to Treat and Microbiologic Evaluable populations TOC - Day 70 Clostridium difficile Infection-Daily Symptoms (CDI DaySyms) change from baseline to each post-baseline visit in domain scores (diarrhea symptoms, abdominal symptoms, and systemic/other symptoms) in the Micro-ITT and ME populations Screening through TOC visit and at suspected recurrence Time to recurrence of Clostridioides difficile infection through Day 70 in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations from TOC until the date of recurrence, assessed up to Day 70
Trial Locations
- Locations (18)
Om Research, LLC
🇺🇸Lancaster, California, United States
UNC Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
St. Charles Clinical Research
🇺🇸Weldon Spring, Missouri, United States
Providence Facey Medical Foundation/Clinical Research Center
🇺🇸Mission Hills, California, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Ascada Research
🇺🇸Fullerton, California, United States
UCI Center for Clinical Research
🇺🇸Orange, California, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Frontier Clinical Research, LLC
🇺🇸Uniontown, Pennsylvania, United States
Southern Clinical Research
🇺🇸Miami, Florida, United States
London Health Sciences Center and St. Joseph's Health Care London
🇨🇦London, Ontario, Canada
Continental Medical Research, Inc.
🇺🇸Miami, Florida, United States
Beaumont Health
🇺🇸Royal Oak, Michigan, United States
University of Calgary/Foothills Medical Center Alberta Health Services
🇨🇦Calgary, Alberta, Canada
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
Mercy Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States