Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509834
Status:
WITHDRAWN
Last Update Posted:
2015-06-30
First Post:
2007-07-31
Brief Title:
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
Official Title:
A Phase-IIa Double-blind Randomized Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia SLIC Study of Lactoferrin Peptide in Infections With Candida
Status:
WITHDRAWN
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patient population not available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLIC
Brief Summary:
This is a phase-I double-blind randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection
Detailed Description:
RATIONALE FOR THE STUDY
Choice of Drug
Fluconazole is considered standard care for the treatment of Candida infections including candidaemia in hospitalized patients
Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and importantly to be synergistic with fluconazole whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo Furthermore candidaemia bloodstream Candida infection is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation
As previously mentioned fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies whereby the effect of fluconazole is enhanced by the addition of hLF1-11
Choice of Drug
Fluconazole is considered standard care for the treatment of Candida infections including candidaemia in hospitalized patients
Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and importantly to be synergistic with fluconazole whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11
Choice of Patient Population
Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo Furthermore candidaemia bloodstream Candida infection is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation
As previously mentioned fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies whereby the effect of fluconazole is enhanced by the addition of hLF1-11
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