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

Summit Therapeutics27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clostridium Difficile Infection

Interventions

RidinilazoleDRUG

FidaxomicinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Laguna Hills

Laguna Hills, California, United States

Ventura

Ventura, California, United States

Idaho

Idaho Falls, Idaho, United States

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability

Time frame: 30 days post End of Therapy

Secondary Outcomes

To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969

Time frame: 12 days

To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques

Time frame: 40 days

Measure clinical cure rates at the Test of Cure (TOC) visit

Investigator assessed clinical response at the TOC visit (on day 12) with clinical cure defined as the resolution of diarrhoea (≤ 3 Unformed Bowel Movements (UBMs) per day) while on treatment that is maintained until the TOC visit.

Time frame: 12 days

Measure sustained clinical response (SCR) rates

SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).

Time frame: 40 days

Data from ClinicalTrials.gov

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