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

Primary Purpose

Candidaemia

Status

Withdrawn

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

hLF1-11

Placebo

About this trial

This is an interventional treatment trial for Candidaemia focused on measuring hLF1-11, Candida, candidaemia, lactoferrin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

UMC St. Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hLF1-11

Placebo

Arm Description

hLF1-11 0.5mg

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

Outcomes

Primary Outcome Measures

Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.

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.

Full Information

NCT ID

NCT00509834

First Posted

July 31, 2007

Last Updated

June 29, 2015

Sponsor

AM-Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00509834

Brief Title

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

Acronym

SLIC

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 Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Withdrawn

Why Stopped

Patient population not available

Study Start Date

July 2008 (undefined)

Primary Completion Date

January 2009 (Anticipated)

Study Completion Date

January 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AM-Pharma

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Candidaemia

Keywords

hLF1-11, Candida, candidaemia, lactoferrin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

hLF1-11

Arm Type

Experimental

Arm Description

hLF1-11 0.5mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

hLF1-11

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

hLF1-11

Other Intervention Name(s)

human lactoferrin 1-11

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.

Time Frame

28 Days

Secondary Outcome Measure Information:

Title

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Professor P.E. Verweij, MD, PhD

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UMC St. Radboud

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6500 HB

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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