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.
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) |
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1: Placebo Comparator
ALT with placebo with systemic Micafungin therapy
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Drug: Micafungin lock therapy
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2: Experimental
ALT with Micafungin and heparin with systemic Micafungin therapy
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Drug: Micafungin lock therapy
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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.
Purpose
