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

Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092935
• Other study ID #: SMT19969/C002
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2014
• Last updated: October 19, 2016
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: Summit Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Diarrhea

Intervention

Drug:
• SMT19969

• Vancomycin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Summit Therapeutics	Wellcome Trust

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects	Using microbiology, sequencing, metagenomic and bioinformatics techniques.	40 days	No
Primary	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	30 days post End of Therapy	No
Secondary	Plasma and faecal concentrations of SMT19969	Using laboratory analysis	40 Days	No
Secondary	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	40 days	Yes