Clinical trial NCT00809887: Micafungin Lock Therapy
Official title: Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Catheter-Related Fungal Infections
Keywords: catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2008-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.
timeFrame: 96 hours
Secondary outcomes:
measure: Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin
timeFrame: Up to one month
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center of Dallas/University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: