Clinical trial NCT01232595: Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
Official title: Multi-center, Randomized, Evaluator-blind, Active-controlled,Parallel-group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate Clostridium Difficile Infection
Keywords: Clostridium difficile,
C. difficile,
CDI,
Clostridium difficile-associated disease,
CDAD,
pseudomembranous colitis,
PMC,
antibiotic-associated diarrhea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 90 years of age, inclusive.
* 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:

* Severe C. difficile infection
* 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13.
timeFrame: Day 12/13
measure: POC: Safety and tolerability of LFF571
timeFrame: Day 12/13
measure: POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2).
timeFrame: Day 12/13
measure: Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days
timeFrame: Day 12/13
measure: Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571
timeFrame: Day 12/13
measure: Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients.
timeFrame: Day 12/13
Secondary outcomes:
measure: POC: To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients (cohorts 1 and 2)
timeFrame: End of therapy
measure: POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1)
timeFrame: 30 days
measure: POC: To evaluate the sustained response and relapse rate within 30 days following completion of different oral LFF571 dose regimens (cohort 2)
timeFrame: 30 days
measure: POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2)
timeFrame: 30 days
measure: POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2)
timeFrame: 30 days
measure: Cohort 2: Time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients.
timeFrame: Day 12/13
measure: Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients.
timeFrame: Day 12/13
measure: Cohort 2: Fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. Difficile infected patients.
timeFrame: Day 12/13
measure: Cohort 2: Sustained response (sustained clinical cure) rate and clinical relapse rate at 30 days following completion of different oral LFF571 dose regimens.
timeFrame: 30 days
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Novartis Investigative Site
state: California
city: Bristol
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Decatur
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Michigan City
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Butte
country: United States
facility: Novartis Investigative Site
state: Montana
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.