Back to resultsA Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis (LIST)
Primary Purpose
Staphylococcal Infections, Bacteremia
Status
Withdrawn
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
human lactoferrin peptide 1-11
Sponsored by
About this trial
This is an interventional treatment trial for Staphylococcal Infections focused on measuring S. epidermidis, Staphylococcus, Lactoferrin, hLF1-11, Bacteraemia
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients with positive blood culture for Staphylococcus epidermidis.
- Diagnosis of staphylococcal infection based on a positive culture for Staphylococcus epidermidis on 2 consecutive occasions within 12 hours.
- Study medication must be started not later than 24 hours of the last qualifying positive blood culture.
- Patients for whom antibiotic treatment is not clinically indicated at the start of the study.
- Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
- Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
- Fecund females patients must not be pregnant (confirmed by pregnancy test at entry) and must be on appropriate mechanical (intra-uterine device) or pharmacological ("pill") contraception.
- Written informed consent must be obtained before admission in the study.
Exclusion Criteria:
- Prior antibiotic usage: patients who have received (within 48 hours of study entry) a systemic anti-staphylococcal antibiotic for longer than 24 hours.
- Concomitant antibiotic or anti-bacterial agents except as allowed by the protocol or in life-threatening complications.
- Patients with devices infected with Staphylococcus epidermidis or other important pathogens, including in implants, heart valves and catheters.
- Patients known to have AIDS or who are HIV-positive.
- Neutropenic patients with neutrophil count below 0.5x10^9/L.
- Patients with staphylococcal endocarditis, mediastinitis, meningitis, osteomyelitis and/or joint infections, lung/pleural infections, septic shock.
- Patients with methicillin-sensitive coagulase-negative staphylococcus (CNS) infections (MSSE).
- Patients who have known hypersensitivity to any constituent of hLF1-11.
- Patients who have received an investigational drug within three months prior to the study that may interfere with the interpretation of study results.
- Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
- Patients considered inappropriate by the PI for enrolment in the study, for any reason.
Sites / Locations
- UMC St. Radboud
Outcomes
Primary Outcome Measures
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring
Secondary Outcome Measures
Test of Cure (TOC): Microbiological: eradication of Staphylococcus epidermidis bacteria identified at baseline; and Clinical: complete resolution of any clinical signs and symptoms related to bacteraemia due to Staphylococcus epidermidis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00509847
Brief Title
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis
Acronym
LIST
Official Title
A Phase-IIa, Double-blind, Randomized, Controlled Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Bacteremia Due to Staphylococcus Epidermidis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Withdrawn
Why Stopped
conduct (recruitment) not feasible within timeframe
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
AM-Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to establish the tolerability of treatment with human lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10 consecutive days, to patients with bacteremia due to staphylococcus epidermidis.
Detailed Description
RATIONALE FOR THE STUDY
Choice of Drug
Staphylococcus epidermidis is a relatively uncommon find in blood cultures, most cases being found in patients with intravenous lines through contiguous contamination and current clinical practice is often one of not using antibiotic treatment immediately, unless significant clinical signs and symptoms and/or patient status justifies intervention with an antibiotic. The latter tends to be vancomycin as many S epidermidis strains are resistant to other agents.
hLF1-11 is hypothesized to have antibacterial effects against Staphylococcus epidermidis, amongst other strains.
Should hLF1-11 be shown to be an effective antibacterial against Staphylococcus epidermidis, its use would be justified in other more serious hospital-acquired infections such as MRSA for which hLF1-11 has been shown (in preclinical in vitro and in vivo data) to display a strong therapeutic effect.
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess antibacterial effects on the selected bacteria (Staphylococcus epidermidis). Staphylococcus epidermidis is a commensal found in human skin. In current clinical practice hospital-acquired systemic Staphylococcal epidermidis is not routinely treated unless the bacteremia is accompanied by a clear clinical risk to the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections, Bacteremia
Keywords
S. epidermidis, Staphylococcus, Lactoferrin, hLF1-11, Bacteraemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
human lactoferrin peptide 1-11
Other Intervention Name(s)
hLF1-11
Intervention Description
(A) hLF1-11 (once-daily 0.5mg IV for 10 days): Group #1, n=10; OR (B) Placebo (to match hLF1-11): Group #2, n=10
Primary Outcome Measure Information:
Title
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Test of Cure (TOC): Microbiological: eradication of Staphylococcus epidermidis bacteria identified at baseline; and Clinical: complete resolution of any clinical signs and symptoms related to bacteraemia due to Staphylococcus epidermidis
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients with positive blood culture for Staphylococcus epidermidis.
Diagnosis of staphylococcal infection based on a positive culture for Staphylococcus epidermidis on 2 consecutive occasions within 12 hours.
Study medication must be started not later than 24 hours of the last qualifying positive blood culture.
Patients for whom antibiotic treatment is not clinically indicated at the start of the study.
Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
Fecund females patients must not be pregnant (confirmed by pregnancy test at entry) and must be on appropriate mechanical (intra-uterine device) or pharmacological ("pill") contraception.
Written informed consent must be obtained before admission in the study.
Exclusion Criteria:
Prior antibiotic usage: patients who have received (within 48 hours of study entry) a systemic anti-staphylococcal antibiotic for longer than 24 hours.
Concomitant antibiotic or anti-bacterial agents except as allowed by the protocol or in life-threatening complications.
Patients with devices infected with Staphylococcus epidermidis or other important pathogens, including in implants, heart valves and catheters.
Patients known to have AIDS or who are HIV-positive.
Neutropenic patients with neutrophil count below 0.5x10^9/L.
Patients with staphylococcal endocarditis, mediastinitis, meningitis, osteomyelitis and/or joint infections, lung/pleural infections, septic shock.
Patients with methicillin-sensitive coagulase-negative staphylococcus (CNS) infections (MSSE).
Patients who have known hypersensitivity to any constituent of hLF1-11.
Patients who have received an investigational drug within three months prior to the study that may interfere with the interpretation of study results.
Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
Patients considered inappropriate by the PI for enrolment in the study, for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor P.E. Verweij, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC St. Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://www.am-pharma.com
Description
Related Info
Learn more about this trial
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis
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