Candidaemia Clinical Trial
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)
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment