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Sponsored by: |
AM-Pharma |
---|---|
Information provided by: | AM-Pharma |
ClinicalTrials.gov Identifier: | NCT00509834 |
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 |
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) |
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
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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
0.5mg hLF1-11 iv per day for 14 consecutive days
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2: Placebo Comparator
Similar to hLF1-11 iv formulation except for the active component
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Gelderland | |
UMC St. Radboud | |
Nijmegen, Gelderland, Netherlands, 6500 HB |
Principal Investigator: | Professor P.E. Verweij, MD, PhD | UMC St. Radboud Nijmegen, The Netherlands |
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) |
hLF1-11 Candida candidaemia lactoferrin |
Fluconazole Torulopsis |