A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia

NCT ID: NCT00509834

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-01-31

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.

Conditions

Candidaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

hLF1-11

hLF1-11 0.5mg

Group Type: EXPERIMENTAL

hLF1-11

Intervention Type: DRUG

The study treatment consists of IV administration of:

(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10

hLF1-11

Intervention Type: DRUG

0.5mg hLF1-11 iv per day for 14 consecutive days

Placebo

Placebo formulation is Similar to hLF1-11 iv formulation except for the active component

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

hLF1-11

The study treatment consists of IV administration of:

(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10

Intervention Type: DRUG

hLF1-11

0.5mg hLF1-11 iv per day for 14 consecutive days

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

human lactoferrin 1-11

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AM-Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor P.E. Verweij, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

UMC St. Radboud

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

AMP IC 01-01

Identifier Type: -

Identifier Source: org_study_id