Clinical trials: Clostridium Difficile Infection
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, 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 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.
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection, Prophylaxis
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
- Conditions
- Clostridium Difficile Infection, Prophylaxis, Vancomycin
- Trial name
- NCT02951702
- Testing
- Vancomycin Oral
- Volunteers
- 51 people
- Sponsor
- St. Luke's Hospital, Chesterfield, Missouri
Clostridium Infections, Diarrhea
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT00269399
- Testing
- Rifaximin (Xifaxan), Vancomycin
- Where
- 63 sites in United States
- Volunteers
- 237 people
- Sponsor
- Bausch Health Americas, Inc.
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
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01987895
- Testing
- Cadazolid, Vancomycin
- Volunteers
- 632 people
- Sponsor
- Actelion
Prostate Cancer, Urinary Tract Infection
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy.
- Conditions
- Prostate Cancer, Urinary Tract Infection, Clostridium Difficile
- Trial name
- Abx (NCT02247960)
- Testing
- Ciprofloxacin
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- University of Rochester
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
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…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection Recurrence
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C.
- Trial name
- NCT03617445
- Testing
- FMT oral capsule, Oral Vancomycin
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Wisconsin, Madison
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
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.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
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
Gastrointestinal Bleeding, Stress Ulcers
Stress Ulcer Prophylaxis in the Intensive Care Unit
Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.
- Trial name
- SUP-ICU (NCT02467621)
- Testing
- Pantoprazole, Saline (0.9%)
- Where
- 33 sites in Denmark, Finland and 4 more
- Volunteers
- 3,350 people
- Sponsor
- Dr. Morten Hylander Møller
Diarrhoea, Clostridium Difficile
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically…
- Trial name
- NCT01570634
- Testing
- Calcium Aluminosilicate Anti-Diarrheal (CASAD)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Salient Pharmaceuticals Incorporated
Clostridium Infections, Diarrhea
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
- Trial name
- NCT00314951
- Testing
- Fidaxomicin, Vancomycin
- Volunteers
- 629 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridium Difficile Infection
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization…
- Trial name
- NCT01259726
- Testing
- VP20621
- Where
- 59 sites in United States, Belgium and 4 more
- Volunteers
- 173 people
- Sponsor
- Shire
Clostridium Difficile Infection
Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection).
- Trial name
- NCT02395848
- Testing
- Fidaxomicin
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- McMaster University
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
Clostridium Difficile Infection
Fecal Microbiota Transplant for Primary CDI
Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated…
- Trial name
- NCT03795233
- Testing
- Fecal microbiota transplant G3 capsules, Oral Vancomycin alone
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Boston Medical Center