A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
NCT ID: NCT02784002
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2014-12-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ridinilazole (SMT19969)
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
Ridinilazole
Fidaxomicin
200 mg tablet of Fidaxomicin twice a day for 10 days
Fidaxomicin
Interventions
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Ridinilazole
Fidaxomicin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Summit Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Summit Therapeutics
Locations
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Laguna Hills
Laguna Hills, California, United States
Ventura
Ventura, California, United States
Idaho
Idaho Falls, Idaho, United States
Butte
Butte, Montana, United States
New Jersey
Somers Point, New Jersey, United States
Liberec
Liberec, , Czechia
Pardubice
Pardubice, , Czechia
Praha
Prague, , Czechia
Zlin
Zlín, , Czechia
Leeds
Leeds, , United Kingdom
Liverpool
Liverpool, , United Kingdom
London
London, , United Kingdom
Manchester
Manchester, , United Kingdom
Newcastle Upon Tyne
Newcastle upon Tyne, , United Kingdom
Oxford
Oxford, , United Kingdom
Wigan
Wigan, , United Kingdom
Countries
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Other Identifiers
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SMT19969/C003
Identifier Type: -
Identifier Source: org_study_id