Micafungin Lock Therapy

Catheter-Related Fungal Infections Clinical Trial

Official title:

Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809887
• Other study ID #: 10882
• Status: Terminated
• Phase: Phase 1
• First received: December 15, 2008
• Last updated: December 15, 2008
• Start date: June 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter-Related Fungal Infections
• Mycoses

Intervention

Drug:
• Micafungin lock therapy

Locations

Country	Name	City	State
United States	Children's Medical Center of Dallas/University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.		96 hours	Yes
Secondary	Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin		Up to one month	Yes