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

NCT ID: NCT00672841

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-01-31

Brief Summary

This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.

Conditions

Invasive Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Standard care/empiric therapy group

Group Type: ACTIVE_COMPARATOR

Empiric antifungal therapy based on physician discretion.

Intervention Type: DRUG

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

1

Active surveillance/ preemptive therapy group

Group Type: EXPERIMENTAL

Preemptive Therapy with Anidulafungin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Eraxis

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
• IV access for administration of study drug
• Subject (or subject's legal representative) able to give written informed consent

Exclusion Criteria

• History of hypersensitivity or intolerance to echinocandin antifungals
• Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
• Pregnant or lactating women
• Treatment with systemic antifungal therapy within the preceding 7 days
• Documented invasive fungal infection at baseline/screening
• Life expectancy less than 2 days or moribund

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly E Hanson, MD

Role: PRINCIPAL_INVESTIGATOR

Utah

Barbara D Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Duke

John Perfect, MD

Role: PRINCIPAL_INVESTIGATOR

Duke

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Hanson KE, Pfeiffer CD, Lease ED, Balch AH, Zaas AK, Perfect JR, Alexander BD. beta-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study. PLoS One. 2012;7(8):e42282. doi: 10.1371/journal.pone.0042282. Epub 2012 Aug 6.

Reference Type: DERIVED

PMID: 22879929 (View on PubMed)

Other Identifiers

GA88517X

Identifier Type: -

Identifier Source: secondary_id

Pro00003161

Identifier Type: -

Identifier Source: org_study_id