Clinical trials: Clostridium Difficile Infection
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile Infection
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population. Primary objectives: To describe the safety profile of all subjects who receive at least 1 injection To describe the…
- Trial name
- NCT01896830
- Testing
- Clostridium difficile Toxoid Vaccine, 0.9% normal saline
- Where
- Japan
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Recurrence of Clostridium Difficile Infection
REBYOTA™ Prospective Registry
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting.
- Trial name
- ROAR (NCT05835219)
- Testing
- REBYOTA™
- Where
- 42 sites in United States
- Volunteers
- 145 people
- Sponsor
- Ferring Pharmaceuticals
Clostridioides Difficile Infection
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered…
- Trial name
- NCT04781387
- Testing
- CRS3123, Active Comparator
- Where
- 20 sites in United States, Canada
- Volunteers
- 43 people
- Sponsor
- Crestone, Inc
Clostridium Infections
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged >…
- Trial name
- NCT00214461
- Testing
- C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg)
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or…
- Trial name
- MODIFY I (NCT01241552)
- Testing
- MK-3415, MK-6072, MK-3415A
- Volunteers
- 1,452 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Infections
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
- Trial name
- NCT00384527
- Testing
- Nitazoxanide, Vancomycin
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- Romark Laboratories L.C.
Clostridioides Difficile Infection
LMN-201 for Prevention of C. Difficile Infection Recurrence
This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
- Trial name
- NCT05330182
- Testing
- LMN-201
- Where
- 15 sites in United States
- Volunteers
- 375 people
- Sponsor
- Lumen Bioscience, Inc.
Clostridium Difficile Infection
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of…
- Trial name
- MODIFY II (NCT01513239)
- Testing
- MK-6072, MK-3415A, SOC
- Volunteers
- 1,203 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.
- Trial name
- NCT01597505
- Testing
- Surotomycin, Vancomycin
- Volunteers
- 606 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridioides Difficile Infection
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
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…
- Trial name
- Ri-CoDIFy 1 (NCT03595553)
- Testing
- Ridinilazole, Vancomycin
- Where
- 149 sites in United States, Argentina and 12 more
- Volunteers
- 759 people
- Sponsor
- Summit Therapeutics
Clostridium Difficile, Clostridium Infections
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a…
- Trial name
- NCT02563106
- Testing
- SYN-004
- Where
- 43 sites in United States, Bulgaria and 5 more
- Volunteers
- 413 people
- Sponsor
- Theriva Biologics, Inc.
Clostridium Infections
C.Difficile Observational Study
D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age…
- Trial name
- NCT06277999
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- AstraZeneca
Clostridium Difficile
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.
- Trial name
- ECOSPOR (NCT02437487)
- Testing
- SER-109
- Where
- 30 sites in United States
- Volunteers
- 89 people
- Sponsor
- Seres Therapeutics, Inc.
Clostridium Difficile Infection
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).
- Trial name
- NCT04247542
- Testing
- Ibezapolstat, Vancomycin
- Where
- 29 sites in United States
- Volunteers
- 53 people
- Sponsor
- Acurx Pharmaceuticals Inc.
Gastroenteritis, Infectious Colitis
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.
- Trial name
- NCT02497417
- Where
- 4 sites in United States
- Volunteers
- 1,021 people
- Sponsor
- Luminex Corporation
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Clostridium Difficile Infection Recurrence
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Single-arm trial to evaluate the safety and efficacy of ACX-362E [ibezapolstat] in patients with recurrent C. difficile infection (CDI).
- Trial name
- NCT07513285
- Testing
- Ibezapolstat
- Where
- 19 sites in United States
- Volunteers
- 20 people
- Sponsor
- Acurx Pharmaceuticals Inc.
Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
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…
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI
- Trial name
- PRISM-EXT (NCT03497806)
- Testing
- CP101
- Where
- 57 sites in United States, Canada
- Volunteers
- 132 people
- Sponsor
- Finch Research and Development LLC.