Clinical trials: Clostridium Difficile Infections
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.
Clostridioides Difficile Infection
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
- Trial name
- Ri-CoDIFy 3 (NCT04802837)
- Testing
- Ridinilazole, Vancomycin
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Summit Therapeutics
Clostridium Difficile Infection
A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for…
- Trial name
- FMTREAT (NCT03053505)
- Testing
- faecal human microbiota transplant (FMT), Vancomycin or Fidaxomicin
- Where
- 3 sites in Hungary
- Volunteers
- 150 people
- Sponsor
- Sejtterapia Kozpont Kft.
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
Diarrhea, Clostridium Infections
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
- Trial name
- NCT00328263
- Testing
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Where
- 8 sites in Canada
- Volunteers
- 472 people
- Sponsor
- Bio-K Plus International Inc.
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
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
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
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.
Clostridioides Difficile Infection
Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI)…
- Trial name
- NCT02437500
- Testing
- SER-109
- Sponsor
- Seres Therapeutics, Inc.
Diarrhoea, Clostridium Difficile
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically…
- Trial name
- NCT01570634
- Testing
- Calcium Aluminosilicate Anti-Diarrheal (CASAD)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Salient Pharmaceuticals Incorporated
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.
Recurrent Clostridioides Difficile Infection
The Clostridioides Difficile Trial of REC-3964
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile…
- Trial name
- ALDER (NCT06536465)
- Testing
- REC-3964
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Recursion Pharmaceuticals Inc.
Clostridium Infections
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
- Trial name
- NCT00384527
- Testing
- Nitazoxanide, Vancomycin
- Where
- 10 sites in United States
- Volunteers
- 50 people
- Sponsor
- Romark Laboratories L.C.
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
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 (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
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
The purpose of this study is to determine whether a single strain capsulated probiotic, when used after standard C. difficile antibiotic therapy, is effective in reducing the risk of infection recurrence mediated by a decrease in…
- Trial name
- NCT05606159
- Testing
- Bacillus velezensis DSM 33864
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novozymes A/S
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
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