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C. Diff clinical trials at UC Davis

3 research studies open to eligible people

Showing trials for
  • A Study to Compare Experimental Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

    open to eligible people ages 18 years and up

    Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

    Los Angeles, California and other locations

  • 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 non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe CDI will be enrolled and randomized in a 2:1 ratio to receive DNV3837 or SOC. 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 versus standard of care (SOC); - 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

    Sacramento, California and other locations

  • An Extension Study Testing Experimental "SER-109" in People With Recurrent Clostridium Difficile Infection (a bacteria the colon)

    “This is an Extension Study for ECOSPOR III study. You may qualify if you had a CDI recurrence prior to the week 8 study visit.”

    open to eligible people ages 18 years and up

    Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.

    Sacramento, California and other locations

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