Micafungin Lock Therapy

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00809887

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Related Fungal Infections	Drug: Micafungin lock therapy	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Anticipated Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h. [96 hours]

Secondary Outcome Measures

Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin [Up to one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Medical Center of Dallas/University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00809887

Other Study ID Numbers:

10882

First Posted:

Dec 17, 2008

Last Update Posted:

Dec 17, 2008

Last Verified:

Nov 1, 2008

Keywords provided by , ,

catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter

Additional relevant MeSH terms:

Mycoses

Micafungin

Study Results

No Results Posted as of Dec 17, 2008