Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Novartis Investigative Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Novartis Investigative Site
  • United States
    • California
      • Palm Desert, California, United States, 92211
        • Novartis Investigative Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Novartis Investigative Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Novartis Investigative Site
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novartis Investigative Site
    • Texas
      • San Antonio, Texas, United States, 78212
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LFF571 (POC)
Drug: LFF571
Active Comparator: Vancomycin (POC)
Drug: Vancomycin (POC)
Experimental: LFF571 Dose level 1 (cohort 2)
Drug: LFF571
Experimental: LFF571 Dose level 2 (cohort 2)
Drug: LFF571
Experimental: LFF571 Dose level 3 (cohort 2)
Drug: LFF571
Experimental: LFF571 Dose level 4 (cohort 2)
Drug: LFF571

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13.
Time Frame: Day 12/13
Day 12/13
POC: Safety and tolerability of LFF571
Time Frame: Day 12/13
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2)
Day 12/13
POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2).
Time Frame: Day 12/13
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days
Day 12/13
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
Time Frame: Day 12/13
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days.
Day 12/13
Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571
Time Frame: Day 12/13
Day 12/13
Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients.
Time Frame: Day 12/13
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.
Day 12/13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POC: To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients (cohorts 1 and 2)
Time Frame: End of therapy
End of therapy
POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1)
Time Frame: 30 days
30 days
POC: To evaluate the sustained response and relapse rate within 30 days following completion of different oral LFF571 dose regimens (cohort 2)
Time Frame: 30 days
30 days
POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2)
Time Frame: 30 days
30 days
POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2)
Time Frame: 30 days
30 days
Cohort 2: Time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients.
Time Frame: Day 12/13
Day 12/13
Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients.
Time Frame: Day 12/13
Day 12/13
Cohort 2: Fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. Difficile infected patients.
Time Frame: Day 12/13
Day 12/13
Cohort 2: Sustained response (sustained clinical cure) rate and clinical relapse rate at 30 days following completion of different oral LFF571 dose regimens.
Time Frame: 30 days
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLFF571X2201
  • 2011-000947-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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