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

NCT00509834 | Withdrawn Phase 1 DMC

• 1 other identifier: AMP IC 01-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Candidaemia

Keywords

hLF1-11; Candida; candidaemia; lactoferrin

Outcome Measures

Primary Outcomes (1)

• Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.

  28 Days

Secondary Outcomes (1)

• 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

Study Arms (2)

hLF1-11

EXPERIMENTAL

hLF1-11 0.5mg

Drug: hLF1-11

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

hLF1-11 DRUG

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

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AM-Pharma: lead

Study Sites (1)

UMC St. Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Candidemia; Torulopsis

Interventions

lactoferrin (1-11), human

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor P.E. Verweij, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 30, 2015

Record last verified: 2008-04

Locations

NL (1)