Candidaemia fungal infection
Conditions
Interventions
0.5mg hLF1-11 given once daily for 14 consecutive days.
Sponsors
AM-Pharma B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 0.5x109/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 osteomyetilitis, 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 enrolment in the study, for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of hLF1-11 in patients with proven candidaemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To obtain in vitro and in vivo susceptibility data on Candida infections from patients participating in the study. • To explore the relationship of drug exposure to cure rates (defined as negative blood cultures) in evaluable patients. | — |
Countries
Netherlands
Outcome results
None listed