Clinical trials: Clostridium Difficile
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
Clostridium Difficile Infection
Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
- Trial name
- MATCH (NCT03005379)
- Testing
- Fecal Microbiota Therapy (FMT)
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- VA Office of Research and Development
Clostridioides Difficile Infection
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
- Trial name
- Ri-CoDIFy 3 (NCT04802837)
- Testing
- Ridinilazole, Vancomycin
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Summit Therapeutics
Clostridium Difficile Infection
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy.
- Trial name
- NCT02255305
- Testing
- FMT, Antimicrobials
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Endeavor Health
Clostridia Difficile Colitis, Clostridium; Sepsis
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding the toxin produced by C.
- Trial name
- NCT03756454
- Testing
- Bezlotoxumab, Normal Saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Ohio State University
Clostridium Difficile-associated Diarrhea (CDAD)
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD.
- Trial name
- NCT00177970
- Testing
- intravenous immunoglobulin G (IVIG)
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- University of Pittsburgh
Clostridium Difficile Infection
COMBACTE-CDI Understanding the Burden of C. Difficile Infection
Clostridium difficile infection (CDI) is the most common cause of antibiotic associated diarrhoea in the western world. The infection causes significant diarrhoea, which in some cases can be serious and lead to secondary…
- Trial name
- COMBACTE-CDI (NCT03503474)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 3,240 people
- Sponsor
- University of Leeds
Clostridial Infection, Dysbiosis
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with…
- Conditions
- Clostridial Infection, Dysbiosis, Probiotic Therapy
- Trial name
- NCT03548051
- Testing
- Fecal Microbiota Transplantation (FMT), Saline
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Clostridium Difficile
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites.
- Trial name
- PROCLAIM (NCT03617172)
- Testing
- Misoprostol 100Mcg Tab
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Clostridium Difficile Associated Disease
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine.
- Trial name
- NCT03579459
- Testing
- Clostridium difficile vaccine
- Where
- 24 sites in United States
- Volunteers
- 1,317 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diarrhea, Clostridium Infections
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
- Trial name
- NCT00328263
- Testing
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Where
- 8 sites in Canada
- Volunteers
- 472 people
- Sponsor
- Bio-K Plus International Inc.
Severe Clostridium Difficile Infection, Severe-Complicated/Fulminant Clostridium Difficile Infection
Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)
This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
- Trial name
- NCT03970200
- Testing
- Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002, Penn Microbiome Therapy - 003
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Pennsylvania
Clostridium Difficile
Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA
Clostridium difficile (C. difficile) is a major pathogen causing serious healthcare-associated diarrheal illness in patients. Prevention of healthcare facility-onset C. difficile infection (CDI) is essential.
- Trial name
- GLORI (NCT04036058)
- Testing
- Universal gloving
- Where
- 6 sites in United States
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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-Associated Diarrhea (CDAD)
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell…
- Trial name
- DEFLECT-1 (NCT01691248)
- Testing
- fidaxomicin
- Volunteers
- 611 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Inflammatory Bowel Diseases, Clostridium Difficile Infection
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease…
- Trial name
- ICON-2 (NCT03829475)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Brigham and Women's Hospital
Inflammatory Bowel Diseases, Clostridium Difficile Infection
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT.
- Trial name
- NCT03106844
- Testing
- Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Brigham and Women's Hospital
Clostridium Difficile-associated Diarrhea
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01591863
- Testing
- fidaxomicin
- Volunteers
- 38 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Inflammatory Bowel Diseases, Ulcerative Colitis
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections
- Trial name
- NCT04626947
- Testing
- Bezlotoxumab
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- David Binion, MD