Moderate Clostridium Difficile Infection
Conditions
Keywords
Clostridium difficile,, C. difficile,, CDI,, Clostridium difficile-associated disease,, CDAD,, pseudomembranous colitis,, PMC,, antibiotic-associated diarrhea
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.
Interventions
DRUGLFF571
DRUGVancomycin (POC)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. | Day 12/13 | — |
| POC: Safety and tolerability of LFF571 | Day 12/13 | Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2) |
| POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). | 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 |
| 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 | 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. |
| Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 | 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. | Day 12/13 | Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1) | 30 days | — |
| Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients. | 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. | 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 |
| POC: To evaluate the sustained response and relapse rate within 30 days following completion of different oral LFF571 dose regimens (cohort 2) | 30 days | — |
| Cohort 2: Fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. Difficile infected patients. | Day 12/13 | — |
| POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2) | 30 days | — |
| POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2) | 30 days | — |
| Cohort 2: Time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients. | Day 12/13 | — |
| POC: To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients (cohorts 1 and 2) | End of therapy | — |
Countries
Canada, United States
Outcome results
None listed