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

Summit Therapeutics

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Infection

Treatments: Drug: SMT19969; Drug: Vancomycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02092935

SMT19969/C002

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

SMT19969

Experimental group

Description:

200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day

Treatment:

Drug: SMT19969

Vancomycin

Active Comparator group

Description:

125 mg capsule four times a day for 10 days

Treatment:

Drug: Vancomycin