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

Candidaemia Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00509834
• Other study ID #: AMP IC 01-01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 31, 2007
• Last updated: June 29, 2015
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2008
• Source: AM-Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidaemia
• Candidemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	UMC St. Radboud	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
AM-Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.		28 Days	Yes
Secondary	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.		28 Days	No