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C. Diff clinical trials at University of California Health

4 in progress, 1 open to eligible people

Showing trials for
  • A Study to Evaluate Experimental Antibiotic "DNV3837" in Subjects with C. diff Infection

    open to eligible people ages 18 years and up

    This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts. In Part 1 of the study, 10 subjects of either sex with severe or non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe or non-severe CDI will be enrolled to receive DNV3837. In both parts of the study, treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total maximum daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are: - To evaluate the safety of intravenous (IV) DNV3837; - To evaluate the efficacy of IV DNV3837; - To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces; - To assess C. difficile using microbiological assessments; - To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and - To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis

    at UC Davis

  • A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

    Sorry, in progress, not accepting new patients

    This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.

    at UCSF

  • Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

    Sorry, not currently recruiting here

    Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

    at UCLA

  • Fecal Microbiota Transplant National Registry

    Sorry, not currently recruiting here

    A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

    at UCSD UCSF

Our lead scientists for C. Diff research studies include .

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