Micafungin Lock Therapy

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Echinocandins; Micafungin

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.