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NCT04781387 | Active, not recruiting | Clostridioides Difficile Infection

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

Condition or disease

Clostridioides Difficile Infection

Intervention/treatment

Srsaa 123

Active Comparator

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 108 participants
Masking : Quadruple
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 : February 2024
Estimated Study Completion Date : April 2024
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

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

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Adults, ≥ 18 years of age.
  • More than or equal to 3 diarrheal (Bristol Stool Scale scores 5, 6, or 7) stools/day in a 24-hour period during screening 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 antigen using an FDA or Health Canada approved/cleared EIA or ELISA laboratory test.
  • Participants with a primary episode or first recurrence of CDI are eligible.
  • In the judgment 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.
  • Female participants of childbearing potential must not be pregnant, plan to become pregnant during the study, or be breastfeeding; and must be willing to commit to either sexual abstinence or use highly effective methods of birth control contraception from screening through Day 70.
  • Males must use a condom and spermicide from screening through Day 70 (if the female partner(s) is of childbearing potential) and must not donate sperm from screening through Day 70.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.
    • Exclusion Criteria
  • Participants with any of the following conditions
    • Intractable vomiting preventing oral medication intake
    • Severe underlying disease with an expected survival time less than the duration of the study (approximately 70 days).
    • More than 1 prior CDI occurrence within the last 3 months or more than 2 prior episodes of CDI in the last 12 months.
    • A history of a recent CDI episode within 3 months prior to enrollment that was non- responsive to vancomycin.
    • In the investigator's opinion, the participant is anticipated to require oral or intravenous systemic antibiotic therapy for a non-CDI infection between screening and Day 70.
    • Inflammatory bowel disease (Crohn's disease or ulcerative colitis), uncorrected Hirschsprung's disease, short gut syndrome, or any other condition known to significantly impact bowel motility and/or malabsorption.
    • Any other known pathogen associated with diarrhea.
    • Life-threatening or fulminant CDI as defined by IDSA/SHEA Guidelines.
    • Colonic perforation.
    • Need for concurrent laxatives or tube feeds, toxin binders, bile acid sequestrants during the study. Microbiota restoration therapy (MRT) or any phage therapy within 1 year of randomization. Receipt of bezlotoxumab within 3 months of randomization.
    • Participants treated with another antimicrobial agent directed at the current episode of CDI (metronidazole, fidaxomicin, rifaximin, tigecycline, or oral vancomycin) for >24 hours of treatment within the 3 days prior to randomization will not be eligible for enrollment.
    • Pregnant or breastfeeding women.
    • Receipt of any investigational medication during the last month (30 days or 5 half lives, whichever is longer) prior to randomization.
    • Active and uncontrolled HIV with CD4 <200/mm3.
    • Presence of active malignancy undergoing chemotherapy that is expected to cause significant immunosuppression, hematologic malignancy undergoing induction chemotherapy, or recent bone marrow or solid organ transplant (within 1 month prior to randomization) undergoing treatment with medications for the rejection of transplantation. In the investigator's opinion, is expected not to survive through the duration of the study (approximately 70 days) due to complications of the malignancy, or in the investigator's opinion will require oral or intravenous systemic antibiotic therapy during the study for malignancy related conditions.
    • Severe neutropenia defined as ANC <500 cells/mm3
    • Severe hepatic impairment at screening including clinical signs of cirrhosis, end-stage hepatic disease (eg, ascites, hepatic encephalopathy), or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x upper limit of normal (ULN) or total bilirubin ≥ 2x ULN.
    • Any other surgical or medical condition (including a clinically significant laboratory abnormality) as determined by the investigator or the medical monitor, that could interfere with the participant's ability to participate in the study, the administration of study treatment, and/or the interpretation of study results that, in the investigator's opinion, may confound study assessments or study procedures.
    • Known hypersensitivity to CRS3123 or oral vancomycin.
    • An employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as a family member of the employee or the investigator.
    • Unwillingness to stop consuming non-dietary probiotics from randomization to Day 70.
    • Participants currently taking digoxin within 1 week of screening.
    • Unwillingness to refrain from consumption of grapefruit and its juices as well as nutraceutical supplements containing curcumin from randomization until 24 hours after EOT.
    • Unwillingness to stop use of anti-diarrheals from randomization to Day 70.
    • Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection

    Location Details

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

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, California

    Ascada Research

    Fullerton, California, United States, 92835

    Not yet recruiting

    United States, California

    Om Research, LLC

    Lancaster, California, United States, 93534

    Not yet recruiting

    United States, California

    Providence Facey Medical Foundation/Clinical Research Center

    Mission Hills, California, United States, 91345

    Not yet recruiting

    United States, California

    UCI Center for Clinical Research

    Orange, California, United States, 92868

    Not yet recruiting

    United States, Florida

    Southern Clinical Research

    Miami, florida, United States, 33125

    Not yet recruiting

    United States, Florida

    Continental Medical Research, Inc.

    Miami, florida, United States, 33144

    Not yet recruiting

    United States, Georgia

    Gastrointestinal Specialists of Georgia

    Marietta, Georgia, United States, 30060

    Not yet recruiting

    United States, Idaho

    Snake River Research, PLLC

    Idaho Falls, Idaho, United States, 83404

    Not yet recruiting

    United States, road cancer

    Beaumont Health

    Royal Oak, road cancer, United States, 48073

    Not yet recruiting

    United States, Missouri

    St. Charles Clinical Research

    Weldon Spring, missouri, United States, 63304

    Not yet recruiting

    United States, Montana

    Mercy Street Medical Group, PLLC

    Butte, Montana, United States, 59701

    Not yet recruiting

    United States, New York

    Montefiore Medical Center

    Bronx, New York, United States, 10467

    Not yet recruiting

    United States, North Carolina

    UNC Medical Center

    Chapel Hill, North Carolina, United States, 27514

    Not yet recruiting

    United States, Pennsylvania

    Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, United States, 15401

    Not yet recruiting

    United States, Texas

    Houston Endoscopy and Research Center

    Houston, Texas, United States, 77079

    Not yet recruiting

    United States, Texas

    Southern Star Research Institute, LLC

    Saint Anthony, Texas, United States, 78229

    Not yet recruiting

    Canada, Alberta

    University of Calgary/Foothills Medical Center Alberta Health Services

    Calgary, Alberta, Canada, Tanats

    Not yet recruiting

    Canada, Ontario

    London Health Sciences Center and St. Joseph's Health Care London

    London, Ontario, Canada, N6A 4V2