Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
NCT ID: NCT01232595
Last Updated: 2020-12-19
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
109 participants
INTERVENTIONAL
2010-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LFF571 (POC)
LFF571
Vancomycin (POC)
Vancomycin (POC)
LFF571 Dose level 1 (cohort 2)
LFF571
LFF571 Dose level 2 (cohort 2)
LFF571
LFF571 Dose level 3 (cohort 2)
LFF571
LFF571 Dose level 4 (cohort 2)
LFF571
Interventions
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LFF571
Vancomycin (POC)
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with primary episode or first relapse of moderate C. difficile infection.
Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment.
Exclusion Criteria
* Expected to require more than 10 days of C. difficile infection treatment.
* More than one prior episode of C. difficile infection within the prior 3 months.
* Use of anti-peristaltic drugs (including tincture of opium, metoclopramide, loperamide),, cholestyramine, or colestipol
18 Years
90 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Palm Desert, California, United States
Novartis Investigative Site
Bristol, Connecticut, United States
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Decatur, Georgia, United States
Novartis Investigative Site
Idaho Falls, Idaho, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Michigan City, Indiana, United States
Novartis Investigative Site
Topeka, Kansas, United States
Novartis Investigative Site
Butte, Montana, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Chicoutimi, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, Canada
Countries
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References
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Mullane K, Lee C, Bressler A, Buitrago M, Weiss K, Dabovic K, Praestgaard J, Leeds JA, Blais J, Pertel P. Multicenter, randomized clinical trial to compare the safety and efficacy of LFF571 and vancomycin for Clostridium difficile infections. Antimicrob Agents Chemother. 2015 Mar;59(3):1435-40. doi: 10.1128/AAC.04251-14. Epub 2014 Dec 22.
Bhansali SG, Mullane K, Ting LS, Leeds JA, Dabovic K, Praestgaard J, Pertel P. Pharmacokinetics of LFF571 and vancomycin in patients with moderate Clostridium difficile infections. Antimicrob Agents Chemother. 2015 Mar;59(3):1441-5. doi: 10.1128/AAC.04252-14. Epub 2014 Dec 22.
Related Links
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Results for CLFF571X2201from the Novartis Clinical Trials website
Other Identifiers
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2011-000947-26
Identifier Type: -
Identifier Source: secondary_id
CLFF571X2201
Identifier Type: -
Identifier Source: org_study_id