Clinical trials: C.Difficile Diarrhea
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.
C. Difficile, Diarrhea
Impact of Oral Antibiotic Treatment on C. Difficile
The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or…
- Conditions
- C. Difficile, Diarrhea, Enterocolitis
- Trial name
- C-Diff (NCT02057198)
- Testing
- Fidaxomicin, Metronidazole, Vancomycin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Duke University
Ventilator Associated Pneumonia (VAP), Other Infections
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial
Probiotics are commercially available live bacteria thought to have health benefits when ingested. A literature review of probiotic studies in the intensive care unit (ICU) found that in patients who receive probiotics, there is…
- Conditions
- Ventilator Associated Pneumonia (VAP), Other Infections, Antibiotic-Associated Diarrhea, C-Difficile
- Trial name
- PROSPECT (NCT01782755)
- Testing
- L. rhamnosus GG - Probiotic
- Where
- 14 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- McMaster University
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)
Antibiotic-associated Diarrhea, Clostridium Difficile
Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center.
- Trial name
- NCT02127814
- Testing
- Lactobacillus reuteri
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Case Western Reserve University
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)
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)
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)
Clostridium Difficile, Antibiotic Resistant Infection
Digestive Microbiota Transplant
The digestive microbiota graft is performed in three clinical circumstances: Clostridium difficile colitis is responsible for numerous deaths each year showing a severe prognosis.
- Conditions
- Clostridium Difficile, Antibiotic Resistant Infection, Chronic Diarrhea of Unknown Origin
- Trial name
- NCT03606031
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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
Diarrhea, Clostridium Difficile
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe…
- Trial name
- NCT01401023
- Testing
- Tigecycline
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Gary E. Stein, Pharm.D.
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
IBIS is a prospective, observational study, which aims to assess the cost of CDI per day, hospitalization and year including description of incremental costs in hospitalized patients, and recurrent episodes, in German hospitals.
- Trial name
- IBIS (NCT03141775)
- Testing
- Treatment of CDI
- Where
- 6 sites in Germany
- Volunteers
- 541 people
- Sponsor
- University of Cologne
Clostridium Difficile Diarrhea
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
- Trial name
- NCT02200328
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Alison Schneider
Clostridium Difficile-associated Diarrhea (CDAD)
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD.
- Trial name
- NCT00177970
- Testing
- intravenous immunoglobulin G (IVIG)
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- University of Pittsburgh
Clostridium Difficile Associated Diarrhea (CDAD)
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.
- Trial name
- NCT02835105
- Testing
- Surotomycin
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Clostridium Difficile Infection
Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C.
- Trial name
- NCT01914731
- Testing
- Fecal Microbiota Transplant
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
Antibiotic-associated Diarrhea, Clostridium Difficile
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available.
- Conditions
- Antibiotic-associated Diarrhea, Clostridium Difficile, Diarrhea
- Trial name
- SacBo (NCT01143272)
- Testing
- Saccharomyces boulardii
- Where
- 14 sites in Germany
- Volunteers
- 477 people
- Sponsor
- Bernhard Nocht Institute for Tropical Medicine
Antibiotic-Associated Diarrhea, Clostridium Difficile
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C.
- Trial name
- loperamide (NCT00591357)
- Testing
- loperamide
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Michael E. DeBakey VA Medical Center
Intestinal C. Difficile
Probiotic Intervention With Elderly Subjects
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
- Trial name
- NCT01475942
- Testing
- Probiotic
- Where
- Finland
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Danisco