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

Phase 2

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: SMT19969; Drug: Vancomycin

• Registration Number: NCT02092935
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Study Start: 2014-04
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Disposition First Submitted: 2016-10-13
• Disposition First Submitted QC: 2016-10-13
• Disposition First Posted: 2016-10-17
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMT19969	SMT19969	200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
Vancomycin	Vancomycin	125 mg capsule four times a day for 10 days

Primary Outcome Measures

Name	Time	Method
Evaluate the clinical outcome by assessment of sustained clinical response	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

Name	Time	Method
Plasma and faecal concentrations of SMT19969	40 Days	Using laboratory analysis
To assess the safety and tolerability of SMT19969 compared with vancomycin	40 days	Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study