Clinical trials: Clostridium Difficile
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, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients with recurrent CDAD.
- Trial name
- NCT06839209
- Testing
- Toxclean 1g
- Where
- Italy
- Volunteers
- 18 people
- Sponsor
- ABResearch S.r.l.
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 Associated Diarrhea (CDAD)
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.
- Trial name
- NCT02835118
- Testing
- Surotomycin
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diarrhea
OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)
The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.
- Trial name
- NCT00097422
- Testing
- OPT-80
- Where
- United States
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Clostridium Difficile
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d.
- Trial name
- NCT00417872
- Testing
- Nitazoxanide, Metronidazole
- Where
- 7 sites in United States
- Volunteers
- 114 people
- Sponsor
- Romark Laboratories L.C.
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 Associated Disease
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine.
- Trial name
- NCT03579459
- Testing
- Clostridium difficile vaccine
- Where
- 24 sites in United States
- Volunteers
- 1,317 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Clostridium Difficile-Associated Diarrhea (CDAD)
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell…
- Trial name
- DEFLECT-1 (NCT01691248)
- Testing
- fidaxomicin
- Volunteers
- 611 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Clostridium Difficile-associated Diarrhea
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01591863
- Testing
- fidaxomicin
- Volunteers
- 38 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.