Clinical trial NCT00509834: A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
Official title: A Phase-IIa, Double-blind, Randomized Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia. (SLIC: Study of Lactoferrin Peptide in Infections With Candida)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Candidaemia
Keywords: hLF1-11
Candida
candidaemia
lactoferrin
Lead sponsor: AM-Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: RATIONALE FOR THE STUDY

Choice of Drug

Fluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.

Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11

Choice of Patient Population

Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo. Furthermore, candidaemia (bloodstream Candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation

As previously mentioned, fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hLF1-11.

Eligibility 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.

Primary outcomes:
measure: Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.
timeFrame: 28 Days
Secondary outcomes:
measure: Test of Cure (TOC): Clinical: complete resolution of clinical signs and symptoms or resolution to a point where no further antifungal therapy is judged necessary; and Microbiological: eradication of Candida identified at baseline.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Professor P.E. Verweij, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: