Clinical trials: CDI
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
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the…
- Trial name
- SHIELD (NCT03710694)
- Testing
- DAV132
- Where
- 29 sites in Bulgaria, Germany and 2 more
- Volunteers
- 260 people
- Sponsor
- Da Volterra
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants
- Trial name
- NCT06469151
- Testing
- AZD5148
- Where
- 4 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).
- Conditions
- Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection, Clostridium Difficile, Clostridioides Difficile Infection Recurrence
- Trial name
- CONSORTIUM (NCT03788434)
- Testing
- VE303
- Where
- 37 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Vedanta Biosciences, Inc.
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
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
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or…
- Trial name
- MODIFY I (NCT01241552)
- Testing
- MK-3415, MK-6072, MK-3415A
- Volunteers
- 1,452 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Difficile
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day…
- Trial name
- EXTEND (NCT02254967)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 109 sites in Austria, Belgium and 20 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile…
- Trial name
- MODIFY III (NCT03182907)
- Testing
- Bezlotoxumab, Antibacterial drug treatment (ABD)
- Where
- 75 sites in United States, Argentina and 15 more
- Volunteers
- 148 people
- Sponsor
- Merck Sharp & Dohme LLC
Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI)
Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).
- Trial name
- PROFILE (NCT02437591)
- Testing
- fidaxomicin
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Europe Ltd.
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant, Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
SYN-004 Safety and Tolerability in Allo-HCT Subjects
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER)…
- Trial name
- NCT04692181
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Theriva Biologics, 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.
Moderate Clostridium Difficile Infection
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
- Trial name
- NCT01232595
- Testing
- LFF571, Vancomycin (POC)
- Where
- 18 sites in United States, Canada
- Volunteers
- 109 people
- Sponsor
- Novartis Pharmaceuticals
Recurrence of Clostridium Difficile Infection
REBYOTA™ Prospective Registry
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting.
- Trial name
- ROAR (NCT05835219)
- Testing
- REBYOTA™
- Where
- 42 sites in United States
- Volunteers
- 145 people
- Sponsor
- Ferring Pharmaceuticals
Clostridium Difficile Infection
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of…
- Trial name
- MODIFY II (NCT01513239)
- Testing
- MK-6072, MK-3415A, SOC
- Volunteers
- 1,203 people
- Sponsor
- Merck Sharp & Dohme LLC
Diarrhea, Clostridium Difficile Infection
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving…
- Trial name
- NCT00772343
- Testing
- 0.9% Normal Saline, Clostridium difficile toxoid vaccine, Clostridium difficile toxoid vaccine with adjuvant
- Where
- 31 sites in United States, United Kingdom
- Volunteers
- 116 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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 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)