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

October 3, 2017 updated by: Summit Therapeutics

A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Liberec, Czechia
        • Liberec
      • Pardubice, Czechia
        • Pardubice
      • Praha, Czechia
        • Praha
      • Zlin, Czechia
        • Zlin
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds
      • Liverpool, United Kingdom
        • Liverpool
      • London, United Kingdom
        • London
      • Manchester, United Kingdom
        • Manchester
      • Newcastle Upon Tyne, United Kingdom
        • Newcastle upon Tyne
      • Oxford, United Kingdom
        • Oxford
      • Wigan, United Kingdom
        • Wigan
  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Laguna Hills
      • Ventura, California, United States, 93003
        • Ventura
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho
    • Montana
      • Butte, Montana, United States, 59701
        • Butte
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ridinilazole (SMT19969)
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
Drug: Ridinilazole
Other Names:
  • SMT19969
Active Comparator: Fidaxomicin
200 mg tablet of Fidaxomicin twice a day for 10 days
Drug: Fidaxomicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days post End of Therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
Time Frame: 12 days
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
40 days
Measure clinical cure rates at the Test of Cure (TOC) visit
Time Frame: 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.
12 days
Measure sustained clinical response (SCR) rates
Time Frame: 40 days
SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summit Therapeutics

Investigators

  • Study Director: Medical Director, Summit Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMT19969/C003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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