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

Primary Purpose

Clostridioides Difficile Infection

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CRS3123
Active Comparator
Sponsored by
Crestone, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridioides Difficile Infection focused on measuring CDI, Cdiff Infection, Clostridiodes difficile infection, Cdiff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • Mayo ClinicRecruiting
  • Ascada ResearchRecruiting
  • Om Research, LLCRecruiting
  • Providence Facey Medical Foundation/Clinical Research CenterRecruiting
  • UCI Center for Clinical ResearchRecruiting
  • Innovative Clinical ResearchRecruiting
  • St. Jude Clinical Research, LLCRecruiting
  • Southern Clinical ResearchRecruiting
  • Continental Medical Research, Inc.Recruiting
  • Gastrointestinal Specialists of GeorgiaRecruiting
  • Snake River Research, PLLCRecruiting
  • Beaumont HealthRecruiting
  • St. Charles Clinical ResearchRecruiting
  • Mercy Street Medical Group, PLLCRecruiting
  • Montefiore Medical CenterRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Great Lakes Medical ResearchRecruiting
  • Toledo Institute of Clinical Research, Inc.Recruiting
  • Frontier Clinical Research, LLCRecruiting
  • Lowcountry Infectious DiseasesRecruiting
  • Advanced GastroenterologyRecruiting
  • Houston Endoscopy and Research CenterRecruiting
  • Southern Star Research Institute, LLCRecruiting
  • Seattle Infectious Disease ClinicRecruiting
  • University of Calgary/Foothills Medical Center Alberta Health ServicesRecruiting
  • London Health Sciences Center and St. Joseph's Health Care LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CRS3123 200 milligram

CRS3123 400 milligram

Vancomycin 125 milligram

Arm Description

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.

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.

Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.

Outcomes

Primary Outcome Measures

Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population

Secondary Outcome Measures

Rate of Clinical cure at Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
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 to resolution of diarrhea through Test of Cure (TOC) in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
Rate of early recurrence of Clostridioides difficile infection through Follow up visit 3 (Day 40) in the Micro-ITT and ME populations
Rate of late recurrence of Clostridioides difficile infection (between Day 40 and Day 70) in the Micro-Intent to Treat and Microbiologically Evaluable populations
Rate of recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat and Microbiologic Evaluable populations
Time to recurrence of Clostridioides difficile infection through follow up visit 4 in the Micro-Intent to Treat, Per Protocol and Microbiologically Evaluable populations
Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations

Full Information

First Posted
January 19, 2021
Last Updated
September 1, 2023
Sponsor
Crestone, Inc
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04781387
Brief Title
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crestone, Inc
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
Keywords
CDI, Cdiff Infection, Clostridiodes difficile infection, Cdiff

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRS3123 200 milligram
Arm Type
Experimental
Arm Description
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.
Arm Title
CRS3123 400 milligram
Arm Type
Experimental
Arm Description
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.
Arm Title
Vancomycin 125 milligram
Arm Type
Active Comparator
Arm Description
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
Intervention Type
Drug
Intervention Name(s)
CRS3123
Intervention Description
Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days
Intervention Type
Drug
Intervention Name(s)
Active Comparator
Intervention Description
Active comparator is administered 125 mg PO QID
Primary Outcome Measure Information:
Title
Rate of Clinical Cure at Test of Cure (TOC) in the Intention to treat (ITT) population
Time Frame
Day 12-14
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Rate of global cure in the Micro-Intent to Treat, Per Protocol and Microbiologically evaluable populations
Time Frame
Day 12 - Day 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Ribble
Phone
303-668-2516
Email
wribble@crestonepharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jon B. Bruss, MD
Phone
269-352-3766
Email
jbbruss@alarusdevelopment.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Ochsner, PhD
Organizational Affiliation
Crestone, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonas Berhe
Phone
480-301-4750
First Name & Middle Initial & Last Name & Degree
Michele Richardson
Phone
480-342-3985
First Name & Middle Initial & Last Name & Degree
Cuong Nguyen, MD
Facility Name
Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pearl Chen
Phone
657-214-3682
Email
Pearl@ascadaresearch.org
First Name & Middle Initial & Last Name & Degree
Kevin Oei, DO
Facility Name
Om Research, LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Gutierrez
Phone
661-388-2239
Email
jgutierrez@omclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Heather Blunt
Phone
661-388-2239
Email
hblunt@omclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Jatinder Pruthi, MD
Facility Name
Providence Facey Medical Foundation/Clinical Research Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviana Alba
Phone
818-869-7067
Email
viviana.alba@providence.org
First Name & Middle Initial & Last Name & Degree
Michael Okafor
Phone
818-869-7071
Email
michael.okafor@providence.org
First Name & Middle Initial & Last Name & Degree
Magued Beshay, MD
Facility Name
UCI Center for Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalba Magallon
Phone
949-824-8297
Email
rmagallo@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Laura Weisberger
Phone
714-509-6579
Email
weisberl@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Alpesh Amin, MD
Facility Name
Innovative Clinical Research
City
Brighton
State/Province
Colorado
ZIP/Postal Code
80601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Asheim
Phone
720-598-5777
Email
basheim@innovativeclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Thomas Minor, MD
Facility Name
St. Jude Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusmara Villa
Phone
305-507-2273
Email
yvilla@stjudeclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Faride Ramos, MD
Facility Name
Southern Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daineryz Canizares
Phone
844-312-1727
Email
Info@scresearch.us
First Name & Middle Initial & Last Name & Degree
Yunior Silva, MD
Facility Name
Continental Medical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Rodriguez
Phone
855-227-5005
Email
crodriguez.ccresearch@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Carlos Rodriguez
Phone
855-227-5005
Email
contact@ccresearch.us
First Name & Middle Initial & Last Name & Degree
Juan Carlos Moises, MD
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Echols
Phone
678-819-4227
Email
MEchols@gigeorgia.com
First Name & Middle Initial & Last Name & Degree
Aasim Sheikh, MD
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Morrison
Phone
208-535-8406
Email
jmorrison@snakerr.com
First Name & Middle Initial & Last Name & Degree
Richard Nathan, DO
Phone
208-535-8404
Email
rnathan@snakerr.com
First Name & Middle Initial & Last Name & Degree
Richard Nathan, DO
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Highers
Phone
248-551-0099
Email
susan.highers@beaumont.org
First Name & Middle Initial & Last Name & Degree
Carmen DeMarco, MD
Facility Name
St. Charles Clinical Research
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Moushey
Phone
636-477-6366
Email
k.moushey@stcharlesclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Leonard Weinstock, MD
Facility Name
Mercy Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin DeShazo
Phone
406-723-1375
Email
justin.deshazo@mercurystmed.com
First Name & Middle Initial & Last Name & Degree
Misty Johnson
Phone
406-723-1375
Email
misty.johnson@mercurystmed.com
First Name & Middle Initial & Last Name & Degree
John Pullman, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bola Omotosho
Phone
718-920-6565
Email
jomotosh@montefiore.org
First Name & Middle Initial & Last Name & Degree
Paul Riska, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Uribe
Phone
614-293-0775
Email
alberto.uribe@osumc.edu
First Name & Middle Initial & Last Name & Degree
Michael Lyaker, MD
Facility Name
Great Lakes Medical Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davea Dubetz
Phone
440-205-1225
Email
davead@greatlakesgastro.net
First Name & Middle Initial & Last Name & Degree
Christy DeJohn
Phone
440-205-1225
Email
cdejohn@thectnx.com
First Name & Middle Initial & Last Name & Degree
Keith A Friedenberg, MD
Facility Name
Toledo Institute of Clinical Research, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbas Zaidi
Phone
419-843-8815
Email
abbas.zaidi@ohmiallergy.com
First Name & Middle Initial & Last Name & Degree
Syed Rehman, MD
Phone
419-843-8815
Email
smrallergy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Syed Rehman, MD
Facility Name
Frontier Clinical Research, LLC
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Natavio
Phone
724-550-4099
Email
hnativio@frontierclinical.com
First Name & Middle Initial & Last Name & Degree
Kim Chapman
Phone
724-550-4099
Email
kchapman@frontierclinical.com
First Name & Middle Initial & Last Name & Degree
Frederick Ruthardt, MD
Facility Name
Lowcountry Infectious Diseases
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Vasquez
Phone
854-429-1116
Email
aavasquez@lcids.com
First Name & Middle Initial & Last Name & Degree
Kent Stock, DO
Facility Name
Advanced Gastroenterology
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaMonica Connell
Phone
731-884-0600
Email
lamonicaconnell@ucgastro.com
First Name & Middle Initial & Last Name & Degree
Kofi Nuako, MD
Phone
731-884-0600
Email
zeepascal@aol.com
First Name & Middle Initial & Last Name & Degree
Kofi Nuako, MD
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anant Patel
Phone
713-932-6466
Email
anant.patel@workmail.com
First Name & Middle Initial & Last Name & Degree
Vikram Jayanty, MD
Phone
713-932-6466
Email
houston_endoscopy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Vikram Jayanty, MD
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireya Garza
Phone
210-581-2812
Email
mireya.garza@ssrinstitute.com
First Name & Middle Initial & Last Name & Degree
Erika Trevino
Phone
210-581-2812
Email
erika.trevino@ssrinstitute.com
First Name & Middle Initial & Last Name & Degree
Jeff Bullock, MD
Facility Name
Seattle Infectious Disease Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Forrest Ursprung
Phone
206-682-3444
Email
forrestU@Seattleidc.com
First Name & Middle Initial & Last Name & Degree
Brandon Dellinger
Phone
206-682-3444
Email
brandon@seattleidc.com
First Name & Middle Initial & Last Name & Degree
Warren Dinges, MD
Facility Name
University of Calgary/Foothills Medical Center Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Scarcelli
Phone
403-944-1951
Email
dscarcel@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Thomas Louie, MD
Facility Name
London Health Sciences Center and St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Che
Phone
510-646-6100 ext 6573
Email
william.che@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Seema N Parvathy
Phone
510-646-6100 ext 6187
Email
seemanair.parvathy@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Michael Silverman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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