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

Phase 2CompletedNCT02092935

Summit Therapeutics100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Clostridium Difficile Infection

Interventions

SMT19969DRUG

VancomycinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (26)

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Laguna Hills, California, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days post End of Therapy

Secondary Outcomes

Plasma and faecal concentrations of SMT19969

Using laboratory analysis

Time frame: 40 Days

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

Time frame: 40 days

Data from ClinicalTrials.gov

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