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

Novartis Pharmaceuticals109 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Moderate Clostridium Difficile Infection

Interventions

LFF571DRUG

Vancomycin (POC)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (18)

Novartis Investigative Site

Palm Desert, California, United States

Novartis Investigative Site

Bristol, Connecticut, United States

Outcomes

Primary Outcomes

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

POC: Safety and tolerability of LFF571

Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2)

Time frame: 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).

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

Time frame: 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

Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571

Time frame: 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.

Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.

Data from ClinicalTrials.gov

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Secondary Outcomes

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

POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1)

Time frame: 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

POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2)

Time frame: 30 days

POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2)

Time frame: 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

Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients.

Time frame: 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

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