search
Back to results

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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ridinilazole
Fidaxomicin
Sponsored by
Summit Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Laguna Hills
  • Ventura
  • Idaho
  • Butte
  • New Jersey
  • Liberec
  • Pardubice
  • Praha
  • Zlin
  • Leeds
  • Liverpool
  • London
  • Manchester
  • Newcastle Upon Tyne
  • Oxford
  • Wigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ridinilazole (SMT19969)

Fidaxomicin

Arm Description

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

200 mg tablet of Fidaxomicin twice a day for 10 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques
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.
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).

Full Information

First Posted
May 16, 2016
Last Updated
October 3, 2017
Sponsor
Summit Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT02784002
Brief Title
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summit Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ridinilazole (SMT19969)
Arm Type
Experimental
Arm Description
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
Arm Title
Fidaxomicin
Arm Type
Active Comparator
Arm Description
200 mg tablet of Fidaxomicin twice a day for 10 days
Intervention Type
Drug
Intervention Name(s)
Ridinilazole
Other Intervention Name(s)
SMT19969
Intervention Type
Drug
Intervention Name(s)
Fidaxomicin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
Time Frame
12 days
Title
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
Title
Measure clinical cure rates at the Test of Cure (TOC) visit
Description
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
Title
Measure sustained clinical response (SCR) rates
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Summit Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Laguna Hills
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Ventura
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Idaho
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Butte
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
New Jersey
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Liberec
City
Liberec
Country
Czechia
Facility Name
Pardubice
City
Pardubice
Country
Czechia
Facility Name
Praha
City
Praha
Country
Czechia
Facility Name
Zlin
City
Zlin
Country
Czechia
Facility Name
Leeds
City
Leeds
Country
United Kingdom
Facility Name
Liverpool
City
Liverpool
Country
United Kingdom
Facility Name
London
City
London
Country
United Kingdom
Facility Name
Manchester
City
Manchester
Country
United Kingdom
Facility Name
Newcastle Upon Tyne
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Oxford
City
Oxford
Country
United Kingdom
Facility Name
Wigan
City
Wigan
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs