Impact of Rapid Flu Testing in BMC ED

NCT ID: NCT02979730

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2017-12-01

Brief Summary

The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing

Conditions

Influenza-Like Illness; Influenza

Study Design

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

Study Groups

Core Lab Testing Arm

For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B.

Group Type: ACTIVE_COMPARATOR

Core Lab Test

Intervention Type: OTHER

For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.

ED Point of Care Testing Arm

Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B.

Group Type: EXPERIMENTAL

ED Point of Care Test

Intervention Type: OTHER

For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay

Interventions

Core Lab Test

For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.

Intervention Type: OTHER

ED Point of Care Test

For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients 21 years of age or older
• Presenting to the BMC main ED or Urgent Care area with influenza-like illness
• Physician ordered an influenza A/B diagnostic test

Exclusion Criteria

• Previously enrolled in the study
• Any Influenza test result already available at the time approached by the ED RA
• Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
• Unable to give informed consent

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elissa Schechter-Perkins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elissa Perkins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-35841

Identifier Type: -

Identifier Source: org_study_id