Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection (NCT04781387) | Clinical Trial Compass
CompletedPhase 2
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
United States43 participantsStarted 2021-01-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✕
What they're measuring
1
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
✕. 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.