C. Diff clinical trials at University of California Health

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