Micafungin Lock Therapy

Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters

The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.

Study Overview

• Status: Terminated
• Conditions: Catheter-Related Fungal Infections
• Intervention / Treatment: Drug: Micafungin lock therapy

Detailed Description

The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Children's Medical Center of Dallas/University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children, 6 months-18 yrs, with a central line fungal infection, presumed Candida, admitted at Children's Medical Center.
• Signed informed consent by parents and assent by minor if applicable.
• Subjects with likely survival beyond 1 week.

Exclusion Criteria:

• Pocket, tunnel or exit-site infection
• Known allergic reactions to the Micafungin or echinocandins.
• Severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis)
• Mixed infections
• Inability to lock the catheter lumen for minimum 8h because of other medications administration
• Subjects requiring ECMO or CVVH.
• Patients with HIV, congenital immunodeficiencies.
• Positive pregnancy test or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1; ALT with placebo with systemic Micafungin therapy	Drug: Micafungin lock therapy
EXPERIMENTAL: 2; ALT with Micafungin and heparin with systemic Micafungin therapy	Drug: Micafungin lock therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.	96 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin	Up to one month

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ANTICIPATED): June 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: December 15, 2008
• First Submitted That Met QC Criteria: December 15, 2008
• First Posted (ESTIMATE): December 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2008
• Last Update Submitted That Met QC Criteria: December 15, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: 10882