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

• Status: Withdrawn
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AM-Pharma
• Treatments: Lactoferrin

Criteria

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.