Impact of Rapid Flu Testing in BMC ED

NCT02979730 | Completed

• 1 other identifier: H-35841
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to Disposition

  The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record

  By the End of the ED visit (an average time of 4 hours)

Secondary Outcomes (1)

• Delivery of prescription or administration of antibiotics

  by the end of ED visit (an average time of 4 hours)

Study Arms (2)

Core Lab Testing Arm

ACTIVE COMPARATOR

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.

Other: Core Lab Test

ED Point of Care Testing Arm

EXPERIMENTAL

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.

Other: ED Point of Care Test

Interventions

Core Lab Test OTHER

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

Core Lab Testing Arm

ED Point of Care Test 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

ED Point of Care Testing Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Elissa Perkins, MD, MPH

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 2, 2016
• Study Start: February 7, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)