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C. Diff clinical trials at UC Health

13 in progress, 7 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 Clostridium difficile Infection (CDI) 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 UCSD

  • An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile 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 UCLA

  • 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 Clostridium difficile Infection (CDI) 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 UC Davis

  • 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

  • Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

    open to eligible people ages 18 years and up

    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

  • Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection

    open to eligible people ages 18 years and up

    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

  • 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

  • Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

    Sorry, in progress, not accepting new patients

    Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile. Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.

    at UCLA

  • Experimental "SER-109" for the Treatment of Adults With Recurrent Clostridium Difficile Infection (bacteria in the colon)

    “Have you had Clostridium difficile infection (CDI) at least three times in the past 9 months?”

    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

  • Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

    Sorry, not currently recruiting here

    This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

    at UCLA

  • Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

    Sorry, in progress, not accepting new patients

    This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

    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

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