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OpenTrials
Completed

NCT Number: NCT02092935

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

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).

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMT19969

Drug

Vancomycin

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Summit Therapeutics

Industry

Collaborators

  • Wellcome Trust

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2014
Registry last updated
Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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