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

Phase 2

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Ridinilazole; Drug: Fidaxomicin

• Registration Number: NCT02784002
• Lead Sponsor: Summit Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-10
• Disposition First Submitted: 2017-10-03
• Disposition First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-03
• Disposition First Posted: 2017-10-12
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridinilazole (SMT19969)	Ridinilazole	200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
Fidaxomicin	Fidaxomicin	200 mg tablet of Fidaxomicin twice a day for 10 days

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability	30 days post End of Therapy

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969	12 days
Measure sustained clinical response (SCR) rates	40 days	SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).
Measure clinical cure rates at the Test of Cure (TOC) visit	12 days	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.
To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques	40 days

Trial Locations

Locations (16)

Laguna Hills; 🇺🇸 Laguna Hills, California, United States

Ventura; 🇺🇸 Ventura, California, United States

Pardubice; 🇨🇿 Pardubice, Czechia

Liberec; 🇨🇿 Liberec, Czechia

Praha; 🇨🇿 Praha, Czechia

Zlin; 🇨🇿 Zlin, Czechia

London; 🇬🇧 London, United Kingdom

Newcastle Upon Tyne; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Oxford; 🇬🇧 Oxford, United Kingdom

Wigan; 🇬🇧 Wigan, United Kingdom

Butte; 🇺🇸 Butte, Montana, United States

New Jersey; 🇺🇸 Somers Point, New Jersey, United States

Manchester; 🇬🇧 Manchester, United Kingdom

Idaho; 🇺🇸 Idaho Falls, Idaho, United States

Liverpool; 🇬🇧 Liverpool, United Kingdom

Leeds; 🇬🇧 Leeds, United Kingdom