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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02092935
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : October 20, 2016
Wellcome Trust
Information provided by (Responsible Party):
Summit Therapeutics

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).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: SMT19969 Drug: Vancomycin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: SMT19969
200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
Drug: SMT19969
Active Comparator: Vancomycin
125 mg capsule four times a day for 10 days
Drug: Vancomycin

Primary Outcome Measures :
  1. Evaluate the clinical outcome by assessment of sustained clinical response [ Time Frame: 30 days post End of Therapy ]
    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 :
  1. Plasma and faecal concentrations of SMT19969 [ Time Frame: 40 Days ]
    Using laboratory analysis

  2. To assess the safety and tolerability of SMT19969 compared with vancomycin [ Time Frame: 40 days ]
    Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study

Other Outcome Measures:
  1. To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects [ Time Frame: 40 days ]
    Using microbiology, sequencing, metagenomic and bioinformatics techniques.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02092935

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Sponsors and Collaborators
Summit Therapeutics
Wellcome Trust
Study Director: Richard Vickers, PhD Summit (Oxford) Limited