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

Sponsored by:	AM-Pharma
Information provided by:	AM-Pharma
ClinicalTrials.gov Identifier:	NCT00509834

Purpose

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	Intervention	Phase
Candidaemia	Drug: hLF1-11 Drug: Placebo	Phase I Phase II

Drug Information available for: Fluconazole Lactoferrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by AM-Pharma:

Primary Outcome Measures:

Haematology, biochemistry, and microbiological evaluation Adverse event monitoring. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
hLF1-11: Experimental 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
2: Placebo Comparator Similar to hLF1-11 iv formulation except for the active component	Drug: Placebo Placebo

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509834

Locations

Netherlands, Gelderland
UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB

Sponsors and Collaborators

AM-Pharma

Investigators

Principal Investigator:

Professor P.E. Verweij, MD, PhD

UMC St. Radboud Nijmegen, The Netherlands

More Information

Responsible Party:	AM-Pharma ( Dr J Arend, MD )
Study ID Numbers:	AMP IC 01-01
Study First Received:	July 31, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00509834
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AM-Pharma:

hLF1-11
Candida
candidaemia
lactoferrin

Study placed in the following topic categories:

Fluconazole
Torulopsis

ClinicalTrials.gov processed this record on January 16, 2009