Clinical trials: Clostridioides Difficile
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.
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.
Vancomycin Resistant Enterococci Infection, Clostridium Difficile Infection
Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial
With the construction of a new medical teaching ward with features designed to reduce hospital-acquired infections, we hypothesized that the design of the new ward was the major factor that contributed to the improved outcomes…
- Conditions
- Vancomycin Resistant Enterococci Infection, Clostridium Difficile Infection, Nosocomial Infection, Methicillin Resistant Staphylococcus Aureus Infection (MRSA)
- Trial name
- NCT00563186
- Testing
- Admission to a novel hospital ward
- Where
- Canada
- Volunteers
- 1,514 people
- Sponsor
- University of Calgary
Antibiotic-associated Diarrhea, Clostridium Difficile
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available.
- Conditions
- Antibiotic-associated Diarrhea, Clostridium Difficile, Diarrhea
- Trial name
- SacBo (NCT01143272)
- Testing
- Saccharomyces boulardii
- Where
- 14 sites in Germany
- Volunteers
- 477 people
- Sponsor
- Bernhard Nocht Institute for Tropical Medicine
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
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
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, 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 Diarrhea
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
- Trial name
- NCT02200328
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Alison Schneider
Clostridium Difficile Infection, C.Difficile Diarrhea
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo.
- Conditions
- Clostridium Difficile Infection, C.Difficile Diarrhea, CDI
- Trial name
- GRAFT (NCT03621657)
- Testing
- Low Dose FMT Capsule DE, Single Dose FMT Capsule DE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Wisconsin, Madison
Gastrointestinal Hemorrhage, Clostridium Difficile Colitis
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI…
- Trial name
- NCT01477320
- Testing
- Pantoprazole 40 mg IV daily and tube feed.
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Mohamed Saad
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 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.
Clostridium Difficile Associated Disease
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules.
- Trial name
- NCT02561195
- Testing
- Clostridium difficile Vaccine
- Where
- 17 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Pfizer
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 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
Effects of Gastric Acid on Colonic Microbiome
The colonic microbiome is essential in human health and disease. Clostridium difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused by antibiotics which perturb the microbiome and allow C.
- Trial name
- NCT01901276
- Testing
- Omeprazole 40 mg bid
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Daniel Freedberg, MD
Diarrhea, Clostridium Difficile
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe…
- Trial name
- NCT01401023
- Testing
- Tigecycline
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Gary E. Stein, Pharm.D.
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)
Clostridium Difficile Infection (CDI)
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI.
- Trial name
- NCT02692651
- Testing
- Fidaxomicin, Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of Michigan