Micafungin Lock Therapy

Phase 1

Terminated

• Conditions: Catheter-Related Fungal Infections
• Interventions: Drug: Micafungin lock therapy

• Registration Number: NCT00809887
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-06
• Status Verified: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Last Update Submitted: 2008-12-15
• Study First Posted: 2008-12-17
• Last Update Posted: 2008-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Micafungin lock therapy	ALT with placebo with systemic Micafungin therapy
2	Micafungin lock therapy	ALT with Micafungin and heparin with systemic Micafungin therapy

Primary Outcome Measures

Name	Time	Method
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.	96 hours

Secondary Outcome Measures

Name	Time	Method
Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin	Up to one month

Trial Locations

Locations (1)

Children's Medical Center of Dallas/University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States