NCT00509847

A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S. Epidermidis

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AM-Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcal Infections
• Bacteremia

Interventions

Type	Name	Description
DRUG	human lactoferrin peptide 1-11	(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

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2007-08-01
• Last updated: 2014-05-28

Locations

1 site across 1 country: Netherlands