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

This study has been terminated.
(Patient population not available)
Sponsor:
Information provided by:
AM-Pharma
ClinicalTrials.gov Identifier:
NCT00509834
First received: July 31, 2007
Last updated: October 16, 2008
Last verified: April 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

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
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

Other Name: hLF1-11
Drug: hLF1-11
0.5mg hLF1-11 iv per day for 14 consecutive days
Other Name: human lactoferrin 1-11
Placebo Comparator: 2
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
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

No publications provided

Responsible Party: Dr J Arend, MD, AM-Pharma
ClinicalTrials.gov Identifier: NCT00509834     History of Changes
Other Study ID Numbers: AMP IC 01-01
Study First Received: July 31, 2007
Last Updated: October 16, 2008
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

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014