β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

December 31, 2010

Study Completion Date

January 31, 2011

Conditions
Invasive Candidiasis
Interventions
DRUG

Preemptive Therapy with Anidulafungin

Subjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days.

DRUG

Empiric antifungal therapy based on physician discretion.

Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Duke University

OTHER