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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014