A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia (NCT00509834) | Clinical Trial Compass
WithdrawnPhase 1/2
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
Stopped: Patient population not available
Netherlands0Started 2008-07
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 considere…
What they're measuring
1
Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.