A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

Summit Therapeutics

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Infection

Treatments: Drug: Fidaxomicin; Drug: Ridinilazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02784002

SMT19969/C003

Details and patient eligibility

About

The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent
• Clinical diagnosis of CDI plus laboratory diagnostic test
• No more than 30 hours antimicrobial treatment for current CDI episode
• Female subjects of childbearing potential must use adequate contraception

Exclusion criteria

• Life-threatening or fulminant CDI
• Subjects with 2 or more episodes of CDI in the previous year
• Females who are pregnant or breastfeeding
• History of inflammatory bowel disease
• Co-administration of potent P-glycoprotein inhibitors
• Participation in other Clinical research studies within one month of screening
• Subjects that the Investigator feels are inappropriate for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Ridinilazole (SMT19969)

Experimental group

Description:

200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days

Treatment:

Drug: Ridinilazole

Fidaxomicin

Active Comparator group

Description:

200 mg tablet of Fidaxomicin twice a day for 10 days

Treatment:

Drug: Fidaxomicin