Moderate Clostridium Difficile InfectionPhase 2NCT01232595
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
A Phase 2 study testing LFF571 and Vancomycin (POC) in people with Moderate Clostridium Difficile Infection, run by Novartis Pharmaceuticals at 18 sites in 2 countries.
Trial summary
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Moderate Clostridium Difficile Infection
- What is being tested?
- LFF571 and Vancomycin (POC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Oct 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States14 sites
Novartis Investigative Site
Bristol, Connecticut, 06010
Novartis Investigative Site
Butte, Montana, 59701
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigative Site
Decatur, Georgia, 30030
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Idaho Falls, Idaho, 83404
Novartis Investigative Site
Michigan City, Indiana, 46360
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Palm Desert, California, 92211
Novartis Investigative Site
San Antonio, Texas, 78212
Novartis Investigative Site
Topeka, Kansas, 66606
Canada4 sites
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6
Novartis Investigative Site
Hamilton, Ontario, L8N 4A6
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9
About this study
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
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
- Conditions
- Moderate Clostridium Difficile Infection
- Being tested
- LFF571, Vancomycin (POC)
- Keywords
- Clostridium difficile,, C. difficile,, CDI,, Clostridium difficile-associated disease,, CDAD,, pseudomembranous colitis,, PMC,, antibiotic-associated diarrhea
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFF571Drug
Vancomycin (POC)Drug
| Study group | Role | What they receive |
|---|---|---|
| LFF571 (POC) | Experimental | Not described Receives: Drug: LFF571 |
| Vancomycin (POC) | Active comparator | Not described Receives: Drug: Vancomycin (POC) |
| LFF571 Dose level 1 (cohort 2) | Experimental | Not described Receives: Drug: LFF571 |
| LFF571 Dose level 2 (cohort 2) | Experimental | Not described Receives: Drug: LFF571 |
| LFF571 Dose level 3 (cohort 2) | Experimental | Not described Receives: Drug: LFF571 |
| LFF571 Dose level 4 (cohort 2) | Experimental | Not described Receives: Drug: LFF571 |
What is being measured
The primary outcome is the main question the study is designed to answer.
POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13.
Measured: 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)
Measured: 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
Measured: 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
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.
Measured: Day 12/13
Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571
Measured: 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.
Measured: Day 12/13
Secondary outcomes (9)
POC: To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients (cohorts 1 and 2)
Measured: End of therapy
POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1)
Measured: 30 days
POC: To evaluate the sustained response and relapse rate within 30 days following completion of different oral LFF571 dose regimens (cohort 2)
Measured: 30 days
POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2)
Measured: 30 days
POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2)
Measured: 30 days
Cohort 2: Time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients.
Measured: Day 12/13
Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients.
Measured: Day 12/13
Cohort 2: Fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. Difficile infected patients.
Measured: 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.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232595
- Sponsor's protocol ID
- CLFF571X2201
- Other IDs
- 2011-000947-26
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25534727Bhansali 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.
PubMed 25534724
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01232595
- Acronym / sponsor ID
- CLFF571X2201
- Conditions
- Moderate Clostridium Difficile Infection
- Keywords
- Clostridium difficile,, C. difficile,, CDI,, Clostridium difficile-associated disease,, CDAD,, pseudomembranous colitis,, PMC,, antibiotic-associated diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LFF571 (POC) | Experimental | Drug: LFF571 |
| Vancomycin (POC) | Active comparator | Drug: Vancomycin (POC) |
| LFF571 Dose level 1 (cohort 2) | Experimental | Drug: LFF571 |
| LFF571 Dose level 2 (cohort 2) | Experimental | Drug: LFF571 |
| LFF571 Dose level 3 (cohort 2) | Experimental | Drug: LFF571 |
| LFF571 Dose level 4 (cohort 2) | Experimental | Drug: LFF571 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LFF571 | Drug | LFF571 (POC), LFF571 Dose level 1 (cohort 2), LFF571 Dose level 2 (cohort 2), LFF571 Dose level 3 (cohort 2), LFF571 Dose level 4 (cohort 2) |
| Vancomycin (POC) | Drug | Vancomycin (POC) |
Primary outcome
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
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)
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
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.
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.
Time frame: Day 12/13
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 25534727Mullane 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.
- Derived from this study: PubMed 25534724Bhansali 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.
- Results for CLFF571X2201from the Novartis Clinical Trials websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LFF571 and Vancomycin (POC) in people with Moderate Clostridium Difficile Infection, run by Novartis Pharmaceuticals at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232595, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.