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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04781387
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Clostridioides Difficile Infection Drug: CRS3123 Drug: Active Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : December 28, 2022
Estimated Study Completion Date : February 21, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: CRS3123
Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days

Experimental: 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.

Drug: CRS3123
Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days

Active Comparator: Vancomycin 125 milligram
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
Drug: Active Comparator
Active comparator is administered 125 mg PO QID




Primary Outcome Measures :
  1. Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population [ Time Frame: Day 12-14 ]

Secondary Outcome Measures :
  1. Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations [ Time Frame: Day 12-14 ]
  2. 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 [ Time Frame: Day 12-14 ]
  3. Time to resolution of diarrhea through Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations [ Time Frame: from date of randomization until the date of documented resolution, assessed up to Day 12-14 ]
  4. Rate of early recurrence of Clostridioides difficile infection through Follow up visit 3 (Day 40) in the Micro-ITT and ME populations [ Time Frame: Day 12 - Day 40 ]
  5. Rate of late recurrence of Clostridioides difficile infection (between Day 40 and Day 70) in the Micro-Intent to Treat and Microbiologically Evaluable populations [ Time Frame: Day 40 - Day 70 ]
  6. Rate of recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat and Microbiologic Evaluable populations [ Time Frame: Day 12 - Day 70 ]
  7. Time to recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations [ Time Frame: from Day 12 until the date of recurrence, assessed up to Day 70 ]
  8. Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations [ Time Frame: Day 12 - Day 40 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. 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.
  2. Stool positive for C. difficile GDH plus Toxin A and/or B
  3. Participants with a primary episode or first recurrence of CDI are eligible
  4. 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
  5. Participants may be either inpatient or outpatient

Information from the National Library of Medicine

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): NCT04781387


Contacts
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Contact: Wendy Ribble 303-668-2516 wribble@crestonepharma.com
Contact: Katherine Johnson, DO, MSc 415-637-5220 kjohnson@crestonepharma.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Crestone, Inc
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Urs Ochsner, PhD Crestone, Inc
  Study Documents (Full-Text)

Documents provided by Crestone, Inc:
Informed Consent Form  [PDF] February 23, 2021

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Responsible Party: Crestone, Inc
ClinicalTrials.gov Identifier: NCT04781387    
Other Study ID Numbers: 19-0021
75N93019C00056 ( Other Grant/Funding Number: NIAID )
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crestone, Inc:
CDI
Cdiff Infection
Clostridiodes difficile infection
Cdiff
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses