Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Clostridioides Difficile Infection

Intervention / Treatment
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* Drug: CRS3123
* Drug: Active Comparator


Participation Criteria
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Eligibility Criteria
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More than or equal to 3 diarrheal stools/day in 24 hours prior to randomization and in the judgment of the investigator that C difficile is the likely causative agent for the diarrhea. Stool positive for C. difficile Toxin A and/or B Participants with a primary episode or first recurrence of CDI are eligible In the judgement of the investigator, the expectation that the participant will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study Participants may be either inpatient or outpatient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRS3123 200 milligram<br>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. | Drug: CRS3123<br>* Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days<br>|
| Experimental: CRS3123 400 milligram<br>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. | Drug: CRS3123<br>* Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days<br>|
| Active Comparator: Vancomycin 125 milligram<br>Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days. | Drug: Active Comparator<br>* Active comparator is administered 125 mg PO QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population |  | Day 12-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations |  | Day 12-14 | 
| 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 |  | Day 12-14 | 
| Time to resolution of diarrhea through Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations |  | from date of randomization until the date of documented resolution, assessed up to Day 12-14 | 
| Rate of early recurrence of Clostridioides difficile infection through Follow up visit 3 (Day 40) in the Micro-ITT and ME populations |  | Day 12 - Day 40 | 
| 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 recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat and Microbiologic Evaluable populations |  | Day 12 - Day 70 | 
| Time to recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations |  | from Day 12 until the date of recurrence, assessed up to Day 70 | 
| Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations |  | Day 12 - Day 40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDI, Cdiff Infection, Clostridiodes difficile infection, Cdiff