Clinical trials: Clostridium Difficile Infections
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
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT).
- Trial name
- STOOL (NCT02403622)
- Testing
- Fecal Microbiota Preparation
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Microbiome Health Research Institute
Clostridium Difficile Infection
PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found.
- Trial name
- NCT04259931
- Testing
- microbiome analysis
- Volunteers
- 50 people
- Sponsor
- Hospital Universitario de Cabuenes
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 Infection
Treatment of Initial Clostridium Difficile Infection
Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI)…
- Trial name
- NCT03107169
- Testing
- FMT, Vancomycin
- Volunteers
- 10 people
- Sponsor
- Universidad Autonoma de Nuevo Leon
Clostridia Difficile Colitis
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides…
- Trial name
- TAPER-V2 (NCT07328971)
- Testing
- Fidaxomicin, Vancomycin capsule
- Where
- 2 sites in Canada
- Volunteers
- 500 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Clostridium Difficile Colitis
Optimal Surgical Treatment Of Fulminant Clostridium Difficile Colitis
The investigators hypothesize that minimally invasive ileal diversion with intraoperative colonic lavage using a high volume polyethylene glycol/electrolyte solution will clear Clostridium difficile infection resulting in…
- Trial name
- NCT01441271
- Testing
- Ileal diversion and lavage, total abdominal colectomy
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Massachusetts General Hospital
Clostridium Enterocolitis, Antibiotic-Associated Diarrhea
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
What is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associated diarrhea in patients? This infection…
- Conditions
- Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Pseudomembranous Enterocolitis
- Trial name
- NCT00182429
- Testing
- Metronidazole and Rifampin
- Where
- 4 sites in Canada
- Volunteers
- 100 people
- Sponsor
- McMaster University
Clostridium Difficile Infection
An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84
An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects
- Trial name
- NCT01296386
- Testing
- IC84
- Where
- 3 sites in Austria, Hungary
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
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
Clostridium Infections
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult 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 adults aged 18-55 years…
- Trial name
- NCT00127803
- Testing
- Clostridium difficile vaccine
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Infections
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated…
- Trial name
- NCT00350298
- Testing
- GS-CDA1/MDX-1388, normal saline
- Where
- 29 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- MassBiologics
Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection
Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients.
- Trial name
- NCT06794944
- Testing
- Vancomycin (POC), Fidaxomicin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Clostridium Difficile Infection Recurrence
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and…
- Trial name
- BEZLO (NCT03880539)
- Testing
- bezlotoxumab, Vancomycin Oral
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Kansas Medical Center
Clostridioides Difficile Infection, Stool Microbiome
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by…
- Conditions
- Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence
- Trial name
- BEYOND (NCT05304715)
- Testing
- Bezlotoxumab, Normal saline 0.9% or 5% dextrose water
- Where
- 11 sites in Greece
- Volunteers
- 44 people
- Sponsor
- Hellenic Institute for the Study of Sepsis
Clostridium Difficile
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI.
- Trial name
- NCT03760484
- Testing
- Fidaxomicin 200 mg, fecal microbiota transplantation (FMT)
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
Clostridium Difficile Infection
Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection
- Trial name
- NCT03804736
- Testing
- FMT-c, FMT-c Lactobacillus
- Volunteers
- 21 people
- Sponsor
- Universidad Autonoma de Nuevo Leon
Clostridium Difficile Colitis
Extended Treatment With Vancomycin for Clostridium Difficile Colitis
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics.
- Trial name
- NCT00861887
- Testing
- Standard Vancomycin, Extended Vancomycin
- Where
- United States
- Sponsor
- Corewell Health East
Ulcerative Colitis, Inflammatory Bowel Diseases
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale…
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Clostridioides Difficile Infection
- Trial name
- FRONTIER-UC (NCT07401680)
- Testing
- Lyophilized Fecal Microbiota Transplantation (LFMT)
- Where
- 2 sites in Canada
- Volunteers
- 85 people
- Sponsor
- University of Alberta
Microbial Colonization
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact…
- Trial name
- NCT05515562
- Testing
- Omadacycline Injection
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences