Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509847
Status:
WITHDRAWN
Last Update Posted:
2014-05-28
First Post:
2007-07-31
Brief Title:
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S Epidermidis
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
conduct recruitment not feasible within timeframe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIST
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None