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A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SMT19969
Vancomycin
Sponsored by
Summit Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring CDAD, Clostridium Difficile

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMT19969

Vancomycin

Arm Description

200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day

125 mg capsule four times a day for 10 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma and faecal concentrations of SMT19969
Using laboratory analysis
To assess the safety and tolerability of SMT19969 compared with vancomycin
Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study

Full Information

First Posted
March 18, 2014
Last Updated
October 19, 2016
Sponsor
Summit Therapeutics
Collaborators
Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02092935
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summit Therapeutics
Collaborators
Wellcome Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
CDAD, Clostridium Difficile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMT19969
Arm Type
Experimental
Arm Description
200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
125 mg capsule four times a day for 10 days
Intervention Type
Drug
Intervention Name(s)
SMT19969
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
Evaluate the clinical outcome by assessment of sustained clinical response
Description
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
Time Frame
30 days post End of Therapy
Secondary Outcome Measure Information:
Title
Plasma and faecal concentrations of SMT19969
Description
Using laboratory analysis
Time Frame
40 Days
Title
To assess the safety and tolerability of SMT19969 compared with vancomycin
Description
Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study
Time Frame
40 days
Other Pre-specified Outcome Measures:
Title
To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects
Description
Using microbiology, sequencing, metagenomic and bioinformatics techniques.
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Vickers, PhD
Organizational Affiliation
Summit (Oxford) Limited
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Sylmar
State/Province
California
Country
United States
City
Ventura
State/Province
California
Country
United States
City
Idaho Falls
State/Province
Idaho
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Duluth
State/Province
Minnesota
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Tupelo
State/Province
Mississippi
Country
United States
City
Billings
State/Province
Montana
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Sommers Point
State/Province
New Jersey
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Lima
State/Province
Ohio
Country
United States
City
Rapid City
State/Province
South Dakota
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Hamilton
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29718329
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.
Results Reference
derived
PubMed Identifier
28461207
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.
Results Reference
derived

Learn more about this trial

A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

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