Clinical trials: Clostridioides Difficile Infection
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
- Trial name
- NCT00772954
- Testing
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT03824795
- Testing
- MGB-BP-3
- Where
- 9 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- MGB Biopharma Limited
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, Diarrhea
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.
- Trial name
- NCT01230957
- Testing
- Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant)
- Where
- 30 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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, Clostridium Difficile Infections
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo.
- Conditions
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection
- Trial name
- RESTORATiVE303 (NCT06237452)
- Testing
- VE303
- Where
- 215 sites in United States, Australia and 22 more
- Volunteers
- 852 people
- Sponsor
- Vedanta Biosciences, Inc.
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 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
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
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
- NCT01983683
- Testing
- Cadazolid, Vancomycin
- Volunteers
- 631 people
- Sponsor
- Actelion
Recurrent Clostridium Difficile Infection
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
- Trial name
- NCT01202630
- Testing
- Lactobacillus acidophilus CL1285® and Lactobacillus casei
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Bio-K Plus International Inc.
Clostridium Difficile Infection, Antibiotic Associated Diarrhea
Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea.
- Trial name
- NCT01972932
- Testing
- Bio K+® 2 capsules orally (or via nasogastric tube)
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Bio-K Plus International Inc.
Clostridium Difficile Infection
A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection
A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI)
- Trial name
- NCT06367504
- Testing
- DBMF
- Where
- 4 sites in India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Clostridium Difficile Infection
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II.
- Trial name
- ECOSPORIII (NCT03183128)
- Testing
- SER-109
- Where
- 56 sites in United States, Canada
- Volunteers
- 182 people
- Sponsor
- Seres Therapeutics, Inc.
Clostridium Difficile Infection
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of…
- Trial name
- NCT02830542
- Testing
- SER-262
- Where
- 22 sites in United States
- Volunteers
- 96 people
- Sponsor
- Seres Therapeutics, Inc.
Urinary Tract Infections, Infectious Diarrhea
Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across…
- Conditions
- Urinary Tract Infections, Infectious Diarrhea, Clostridium Difficile Infection, Gastrointestinal Disease
- Trial name
- NCT05008640
- Testing
- TrueLoo™
- Where
- 6 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Toi Labs, Inc.
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 (CDI)
Treatment of Mild-moderate Clostridium Difficile Infection (CDI)
Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days.
- Trial name
- IM-01 (NCT04121169)
- Testing
- IM-01
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- ImmuniMed Inc.
Clostridioides Difficile Infection
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response…
- Trial name
- Ri-CoDIFy 1 (NCT03595553)
- Testing
- Ridinilazole, Vancomycin
- Where
- 149 sites in United States, Argentina and 12 more
- Volunteers
- 759 people
- Sponsor
- Summit Therapeutics
Clostridium Difficile Infection
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).
- Trial name
- DAFNE (NCT02214771)
- Testing
- Fidaxomicin, Treatment for CDI other than fidaxomicin Type
- Where
- 24 sites in France
- Volunteers
- 296 people
- Sponsor
- Astellas Pharma S.A.S.