Clinical trials: CDI
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.
Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated…
- Trial name
- NCT02589847
- Testing
- RBX2660, Standard of Care Antibiotics
- Where
- 30 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Rebiotix Inc.
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving…
- Conditions
- Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea
- Trial name
- NCT03462459
- Testing
- Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 79 people
- Sponsor
- University of Wisconsin, Madison
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
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
Clostridium Difficile Infection
Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries
The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational study to characterize patients with CDI as well as to understand treatment and management of the disease.
- Trial name
- NCT02223715
- Testing
- CDI Pts
- Where
- Japan
- Volunteers
- 600 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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.
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
Chronic Hepatitis C
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
- Trial name
- NCT03501550
- Testing
- CDI-31244, SOF/VEL
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Cocrystal Pharma, Inc.
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 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
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 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
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
Clostridium Difficile Infection, Diarrhea
Study of CB-183,315 in Participants With Clostridium Difficile Infection
This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin…
- Trial name
- NCT01085591
- Testing
- CB-183,315, Vancomycin
- Where
- 32 sites in United States, Canada
- Volunteers
- 210 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Recurrent C. Difficile Infection
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
- Trial name
- NCT03298048
- Testing
- Low fecal microbiota dose, Mid fecal microbiota dose, High fecal microbiota dose
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The University of Texas Health Science Center, Houston