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

NCT00509834 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-06-30

No results posted yet for this study

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

Interventions

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

DRUG

hLF1-11

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Professor P.E. Verweij, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509834 on ClinicalTrials.gov