Clinical trials: Clostridium Difficile Infections
Infections, Clostridium Difficile
Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)
This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
- Trial name
- NCT01716533
- Testing
- Blood sampling, Stool sample collection
- Where
- 5 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- GlaxoSmithKline
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
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 Enterocolitis, Pseudomembranous Colitis
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C.
- Trial name
- NCT00106509
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 140 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Genzyme, a Sanofi Company
Pseudomembranous Colitis, Clostridium Difficile Diarrhea
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD).
- Conditions
- Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
- Trial name
- NCT00382304
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 8 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
Clostridium Difficile
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day…
- Trial name
- EXTEND (NCT02254967)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 109 sites in Austria, Belgium and 20 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Europe Ltd.
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 Difficile Infection
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile…
- Trial name
- MODIFY III (NCT03182907)
- Testing
- Bezlotoxumab, Antibacterial drug treatment (ABD)
- Where
- 75 sites in United States, Argentina and 15 more
- Volunteers
- 148 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Clostridium Difficile Infection
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the…
- Trial name
- NCT03105479
- Testing
- Cadazolid, Vancomycin capsule, Vancomycin solution
- Where
- 20 sites in United States, Belgium and 7 more
- Volunteers
- 1 people
- Sponsor
- Actelion
Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom.
- Conditions
- Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis
- Trial name
- NCT00034294
- Testing
- GT160-246
- Where
- 99 sites in United States, Canada and 2 more
- Volunteers
- 300 people
- Sponsor
- Genzyme, a Sanofi Company
Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI)
Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).
- Trial name
- PROFILE (NCT02437591)
- Testing
- fidaxomicin
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Europe Ltd.
Clostridioides Difficile Infection
Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI)…
- Trial name
- NCT02437500
- Testing
- SER-109
- Sponsor
- Seres Therapeutics, Inc.
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
Recurrent C. Difficile Infection
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
- Trial name
- PRISM4 (NCT05153499)
- Testing
- CP101
- Where
- 68 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Finch Research and Development LLC.
Clostridium Difficile Infection
Clostridium Difficile Vaccine Efficacy Trial
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…
- Trial name
- Clover (NCT03090191)
- Testing
- Clostridium difficile vaccine
- Where
- 426 sites in United States, Argentina and 21 more
- Volunteers
- 17,535 people, healthy volunteers welcome
- Sponsor
- Pfizer
C. Diff. Infections
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Trial name
- NCT04893239
- Testing
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3
- Where
- 3 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lumen Bioscience, Inc.
Moderate Clostridium Difficile Infection
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
- Trial name
- NCT01232595
- Testing
- LFF571, Vancomycin (POC)
- Where
- 18 sites in United States, Canada
- Volunteers
- 109 people
- Sponsor
- Novartis Pharmaceuticals
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
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