To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 14 days.
ID
Source
Brief title
Condition
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the safety of hLF1-11 in patients with proven candidaemia.
Secondary outcome
• 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.
Background summary
hLF1-11 is an antimicrobial peptide comprising the first 11 amino acids found
in the naturally occuring lactoferrin that plays a role in the innate hast
response against bacterial and fungal diseases. Animal infections models have
shown hLF1-11 to be effective in treating infections due to bacteria such as
Staphylococcus aureus and fungi such as Candida albicans and the drug has been
shown to be well tolerated and safe in healthy volunteers as well in
neutropenic patients.
Based on preclinical data hLF1-11 demonstrated:
• To have antimycotic effect of hLF1-11 on Candida species.
• That Invasive candidiasis (bloodstream infection) is one of the most likely
settings to elicit a therapeutic response.
• Fluconazole and hLF1-11 exhibit a synergistic effect, whereby the effect of
fluconazole is enhanced by the addition of hLF1-11.
Study objective
To establish the safety, tolerability, and early efficacy of multiple doses of
hLF1-11 given once daily for 14 days.
Study design
• Randomized, double-blind, parallel group comparison to *standard
care* (fluconazole).
• N= 20 (2 groups of n=10)
• Randomization Ratio: 1:1
All decisions on *tolerability* will be made by the Principal Investigator(s)
in consultation with an Independent Data Safety Monitoring Committee (IDSMC)
who will oversee all safety aspects of the study on an ongoing basis and will
advise the PI(s) and Sponsor including on implementation of stopping rules
under separate protocol (available upon request).
Intervention
0.5mg hLF1-11 given once daily for 14 consecutive days.
Study burden and risks
Extra blood will be drawn through through the central venous catheter.
Rumpsterweg 6
3981 AK, Bunnik
Nederland
Rumpsterweg 6
3981 AK, Bunnik
Nederland
Listed location countries
Age
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 0.5x109/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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003871-38-NL |
| CCMO | NL18760.091.07 |