C. Diff clinical trials at UC Health
11 in progress, 5 open to eligible people
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 Clostridium difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease. 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.
at UCLA
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 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
at UC Davis
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
open to eligible people ages 1-17
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab,
at UCSF
Comparison of 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 achieving comparable cure rates to standard of care, but reducing rates of recurrent disease. 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. Ridinilazole plasma concentration will be assessed in a subset of patients.
at UC Davis UCLA
Fecal Microbiota Transplant National Registry
open to all eligible people
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
Clostridium Difficile Vaccine Efficacy Trial
Sorry, in progress, not accepting new patients
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
at UC Davis UCLA UCSD
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Sorry, in progress, not accepting new patients
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.
at UC Davis
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Sorry, in progress, not accepting new patients
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
at UCLA
Optimal Treatment for Recurrent Clostridium Difficile
Sorry, not currently recruiting here
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
at UCSD
Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection
Sorry, in progress, not accepting new patients
This study will evaluate the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).
at UC Davis
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
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