A phase-I, double-blind, randomized study on the tolerability and early efficacy of hLF1-11 in hospitalized patients with proven candidaemia.
- Conditions
- Candidaemiafungal infection10017528
- Registration Number
- NL-OMON31282
- Lead Sponsor
- AM-Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the safety of hLF1-11 in patients with proven candidaemia.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To obtain in vitro and in vivo susceptibility data on Candida infections from<br /><br>patients participating in the study.<br /><br><br /><br>• To explore the relationship of drug exposure to cure rates (defined as<br /><br>negative blood cultures) in evaluable patients.</p><br>