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

Inclusion Criteria:

• Written informed consent must be obtained before admission in the study.
• Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
• Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
• Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.

Exclusion Criteria:

• Patients with a history of hypersensitivity to fluconazole or hLF1-11.
• Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
• Patients with a history of fluconazole-resistant Candida species within 12 weeks.
• Neutropenic patients with neutrophil count below 0.5x10^9/L.
• Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
• Patients known to have AIDS or who are HIV-positive.
• Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).
• Patients with suspected candida osteomyelitis, endocarditis, or meningitis.
• Patients who have received an investigational drug within three months prior to the study.
• Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
• Patients considered inappropriate by the PI for enrollment in the study, for any reason.