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

Sponsor

AM-Pharma (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00509834

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidaemia	Drug: hLF1-11 Drug: hLF1-11 Drug: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jan 1, 2009

Anticipated Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hLF1-11 hLF1-11 0.5mg	Drug: 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 Drug: hLF1-11 0.5mg hLF1-11 iv per day for 14 consecutive days Other Names: human lactoferrin 1-11
Placebo Comparator: Placebo Placebo formulation is Similar to hLF1-11 iv formulation except for the active component	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: hLF1-11

hLF1-11 0.5mg

Drug: 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

Drug: hLF1-11

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

Other Names:

human lactoferrin 1-11

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Haematology, biochemistry, and microbiological evaluation Adverse event monitoring. [28 Days]

Secondary Outcome Measures

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. [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.