Status:
TERMINATED
Micafungin Lock Therapy
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Catheter-Related Fungal Infections
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
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 antif...
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) fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00809887
Start Date
June 1 2006
End Date
November 1 2008
Last Update
December 17 2008
Active Locations (1)
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1
Children's Medical Center of Dallas/University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390