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Trial record 1 of 1 for:    NCT00809887
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Micafungin Lock Therapy

This study has been terminated.
(Inability to enroll subjects)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00809887
First received: December 15, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention Phase
Catheter-Related Fungal Infections
 Drug: Micafungin lock therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h. [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin [ Time Frame: Up to one month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2006
Study Completion Date: November 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809887

Locations
United States, Texas
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)
  More Information

No publications provided

Responsible Party: Patti Shugarts, KAI Research, Inc.
ClinicalTrials.gov Identifier: NCT00809887     History of Changes
Other Study ID Numbers: 10882
Study First Received: December 15, 2008
Last Updated: December 15, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter

Additional relevant MeSH terms:
Mycoses
Micafungin
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013