Trial record 7 of 20 for:    CDAD AND VANCOMYCIN

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Summit Corporation Plc.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Summit Corporation Plc.
ClinicalTrials.gov Identifier:
NCT02092935
First received: March 18, 2014
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Clostridium Difficile Infection
Drug: SMT19969
Drug: Vancomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Summit Corporation Plc.:

Primary Outcome Measures:
  • Evaluate the clinical outcome by assessment of sustained clinical response [ Time Frame: 30 days post End of Therapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: 40 Days ] [ Designated as safety issue: No ]
    Using laboratory analysis

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


Other Outcome Measures:
  • To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects [ Time Frame: 40 days ] [ Designated as safety issue: No ]
    Using microbiology, sequencing, metagenomic and bioinformatics techniques.


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 2 episodes of CDAD in prior 12 months
  • No previous episode of CDAD within 60 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092935

Contacts
Contact: Ian Foley, Ph.D +44 1235-443-937 Codify@summitplc.com

  Show 21 Study Locations
Sponsors and Collaborators
Summit Corporation Plc.
Wellcome Trust
Investigators
Study Director: David Roblin, MD, FRCP Summit Corporation Plc.
  More Information

No publications provided

Responsible Party: Summit Corporation Plc.
ClinicalTrials.gov Identifier: NCT02092935     History of Changes
Other Study ID Numbers: SMT19969/C002
Study First Received: March 18, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Summit Corporation Plc.:
CDAD
Clostridium Difficile

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014