Micafungin Lock Therapy
Stopped early · Phase 1
Conditions studied: Catheter-Related Fungal Infections
In brief
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.
Key facts
- Study ID
- NCT00809887
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 20
- Starts
- 2006-06-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2008-12-17
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Medical Center of Dallas/University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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