A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
1 other identifier
interventional
100
2 countries
26
Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 20, 2016
October 1, 2016
1.5 years
March 18, 2014
October 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the clinical outcome by assessment of sustained clinical response
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
30 days post End of Therapy
Secondary Outcomes (2)
Plasma and faecal concentrations of SMT19969
40 Days
To assess the safety and tolerability of SMT19969 compared with vancomycin
40 days
Other Outcomes (1)
To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects
40 days
Study Arms (2)
SMT19969
EXPERIMENTAL200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
Vancomycin
ACTIVE COMPARATOR125 mg capsule four times a day for 10 days
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent
- 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
You may not qualify if:
- Life-threatening or fulminant colitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Summit Therapeuticslead
- Wellcome Trustcollaborator
Study Sites (26)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Sylmar, California, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Duluth, Minnesota, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Tupelo, Mississippi, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Butte, Montana, United States
Unknown Facility
Sommers Point, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Lima, Ohio, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Related Publications (2)
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.
PMID: 29718329DERIVEDVickers 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.
PMID: 28461207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Vickers, PhD
Summit (Oxford) Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 20, 2014
Study Start
April 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 20, 2016
Record last verified: 2016-10