Clinical trials: Difficile
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.
Clostridium Difficile Infection Recurrence
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C.
- Trial name
- NCT04891965
- Testing
- ART24
- Where
- 15 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Adiso Therapeutics
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 (C. Difficile)
An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection
This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI.
- Trial name
- NCT03988855
- Testing
- DNV3837
- Where
- 13 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Deinove
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
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion.
- Trial name
- NCT01598311
- Testing
- CB-183,315, Vancomycin
- Volunteers
- 608 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.
- Trial name
- NCT01887912
- Testing
- C. difficile Toxoid Vaccine
- Where
- 335 sites in United States, Australia and 24 more
- Volunteers
- 9,302 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
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
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.
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 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
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.
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
Clostridium Difficile Diarrhea
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated…
- Trial name
- NCT03793686
- Testing
- PBCLN-003
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Prolacta Bioscience
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
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
- Trial name
- FREEDOM (NCT01775397)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 16 sites in Austria, Denmark and 5 more
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Europe Ltd.
Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence
Treatment for Clostridium-difficile Infection With IMM529
This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.
- Trial name
- NCT03065374
- Testing
- IMM-529
- Where
- 2 sites in Israel
- Volunteers
- 9 people
- Sponsor
- Immuron Ltd.
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.