Clinical trial NCT02092935: A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection
Keywords: CDAD
Clostridium Difficile
Lead sponsor: Summit Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Wellcome Trust
First posted: 2014-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluate the clinical outcome by assessment of sustained clinical response
timeFrame: 30 days post End of Therapy
Secondary outcomes:
measure: Plasma and faecal concentrations of SMT19969
timeFrame: 40 Days
measure: To assess the safety and tolerability of SMT19969 compared with vancomycin
timeFrame: 40 days
Other outcomes:
measure: To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects
timeFrame: 40 days
Locations:
city: Mobile
country: United States
state: Alabama
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Ventura
country: United States
state: California
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Billings
country: United States
state: Montana
city: Butte
country: United States
state: Montana
city: Sommers Point
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Rapid City
country: United States
state: South Dakota
city: Seattle
country: United States
state: Washington
city: Hamilton
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Summit (Oxford) Limited
name: Richard Vickers, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.