NCT00509834

A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia

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• Status: Withdrawn
• 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

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.

Conditions

• Candidaemia

Interventions

Type	Name	Description
DRUG	hLF1-11	The study treatment consists of IV administration of: (A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10
DRUG	hLF1-11	0.5mg hLF1-11 iv per day for 14 consecutive days
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-08-01
• Last updated: 2015-06-30

Locations

1 site across 1 country: Netherlands