Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
NCT ID: NCT01259726
Last Updated: 2021-06-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
173 participants
INTERVENTIONAL
2011-06-27
2013-06-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Secondary Prevention of Clostridioides Difficile Using Vancomycin
NCT06979609
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
NCT03462459
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
NCT02830542
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
NCT05266807
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
NCT03497806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
10 mL placebo once daily for 14 days
VP20621 Low Dose and Placebo
VP20621
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
Placebo
10 mL placebo once daily for 14 days
VP20621 High Dose and Placebo
VP20621
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
Placebo
10 mL placebo once daily for 14 days
VP20621 High Dose
VP20621
VP20621 as oral liquid once daily for 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VP20621
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
Placebo
10 mL placebo once daily for 14 days
VP20621
VP20621 as oral liquid once daily for 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.
Exclusion Criteria
2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
3. GI surgery within 6 weeks before the day of randomization
4. Have known immunodeficiency disorder, such as HIV Infection
5. Pregnant or breast feeding females.
6. Concurrent acute life-threatening diseases.
7. Inability to tolerate oral liquids.
8. Have an absolute neutrophil count \< 1000/mm3 at screening
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Modesto, California, United States
Palm Desert, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
Bay Pines, Florida, United States
Jacksonville, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Anderson, Indiana, United States
Lafayette, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Chevy Chase, Maryland, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Novi, Michigan, United States
Royal Oak, Michigan, United States
Sault Ste. Marie, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Albany, New York, United States
New York, New York, United States
North Massapequa, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Lima, Ohio, United States
Toledo, Ohio, United States
Lancaster, Pennsylvania, United States
West Reading, Pennsylvania, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Winchester, Virginia, United States
Tacoma, Washington, United States
Aalst, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Trois-Rivières, Quebec, Canada
Cologne, , Germany
Hanover, , Germany
Leipzig, , Germany
Wilhelmshaven, , Germany
Seville, Andalusia, Spain
Barcelona, Catalonia, Spain
Majadahonda, Communidad de Madrid, Spain
Lugano, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gerding DN, Meyer T, Lee C, Cohen SH, Murthy UK, Poirier A, Van Schooneveld TC, Pardi DS, Ramos A, Barron MA, Chen H, Villano S. Administration of spores of nontoxigenic Clostridium difficile strain M3 for prevention of recurrent C. difficile infection: a randomized clinical trial. JAMA. 2015 May 5;313(17):1719-27. doi: 10.1001/jama.2015.3725.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-020484-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VP20621-200
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.