A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
NCT ID: NCT02092935
Last Updated: 2016-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2014-04-30
2015-10-31
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.
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
NCT01987895
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
NCT01983683
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
NCT00269399
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
NCT00314951
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
NCT00034294
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
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SMT19969
200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
SMT19969
Vancomycin
125 mg capsule four times a day for 10 days
Vancomycin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SMT19969
Vancomycin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception
Exclusion Criteria
* Concurrent use of antibiotics or any other treatments for CDAD
* History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
* Participation in other Clinical research studies within one month of screening
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wellcome Trust
OTHER
Summit Therapeutics
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.
Richard Vickers, PhD
Role: STUDY_DIRECTOR
Summit (Oxford) Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mobile, Alabama, United States
Laguna Hills, California, United States
Long Beach, California, United States
Sylmar, California, United States
Ventura, California, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
Billings, Montana, United States
Butte, Montana, United States
Sommers Point, New Jersey, United States
Rochester, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Lima, Ohio, United States
Rapid City, South Dakota, United States
Seattle, Washington, United States
Hamilton, Ontario, Canada
Montreal, Quebec, Canada
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.
Snydman DR, McDermott LA, Thorpe CM, Chang J, Wick J, Walk ST, Vickers RJ. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a Phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018 Aug 1;73(8):2078-2084. doi: 10.1093/jac/dky135.
Vickers RJ, Tillotson GS, Nathan R, Hazan S, Pullman J, Lucasti C, Deck K, Yacyshyn B, Maliakkal B, Pesant Y, Tejura B, Roblin D, Gerding DN, Wilcox MH; CoDIFy study group. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017 Jul;17(7):735-744. doi: 10.1016/S1473-3099(17)30235-9. Epub 2017 Apr 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMT19969/C002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.