NCT02784002

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

May 16, 2016

Last Update Submit

October 3, 2017

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

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

    30 days post End of Therapy

Secondary Outcomes (4)

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

    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

    40 days

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

    12 days

  • Measure sustained clinical response (SCR) rates

    40 days

Study Arms (2)

Ridinilazole (SMT19969)

EXPERIMENTAL

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

Drug: Ridinilazole

Fidaxomicin

ACTIVE COMPARATOR

200 mg tablet of Fidaxomicin twice a day for 10 days

Drug: Fidaxomicin

Interventions

RidinilazoleDRUG
Also known as: SMT19969
Ridinilazole (SMT19969)
FidaxomicinDRUG
Fidaxomicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Laguna Hills

Laguna Hills, California, 92653, United States

Location

Ventura

Ventura, California, 93003, United States

Location

Idaho

Idaho Falls, Idaho, 83404, United States

Location

Butte

Butte, Montana, 59701, United States

Location

New Jersey

Somers Point, New Jersey, 08244, United States

Location

Liberec

Liberec, Czechia

Location

Pardubice

Pardubice, Czechia

Location

Praha

Prague, Czechia

Location

Zlin

Zlín, Czechia

Location

Leeds

Leeds, United Kingdom

Location

Liverpool

Liverpool, United Kingdom

Location

London

London, United Kingdom

Location

Manchester

Manchester, United Kingdom

Location

Newcastle Upon Tyne

Newcastle upon Tyne, United Kingdom

Location

Oxford

Oxford, United Kingdom

Location

Wigan

Wigan, United Kingdom

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

ridinilazoleFidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Medical Director

    Summit Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 26, 2016

Study Start

December 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

US(5)CZ(4)GB(7)