Trial record 1 of 1 for:    NCT00809887
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Micafungin Lock Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809887
Recruitment Status : Terminated (Inability to enroll subjects)
First Posted : December 17, 2008
Last Update Posted : December 17, 2008
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 2006
Estimated Primary Completion Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin [ Time Frame: Up to one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809887

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)

Responsible Party: Patti Shugarts, KAI Research, Inc. Identifier: NCT00809887     History of Changes
Other Study ID Numbers: 10882
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: November 2008

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:
Antifungal Agents
Anti-Infective Agents