A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis (LIST)
|Staphylococcal Infections Bacteremia||Drug: human lactoferrin peptide 1-11||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|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|
- Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring [ Time Frame: 28 Days ]
- 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 ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Drug: human lactoferrin peptide 1-11
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509847
|UMC St. Radboud|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Professor P.E. Verweij, MD, PhD||UMC St. Radboud, Nijmegen, The Netherlands|