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OpenTrials
Completed

NCT Number: NCT02979730

Impact of Rapid Flu Testing in BMC ED

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

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Key information

Conditions

Influenza-like Illness Infections Influenza Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Time to Disposition

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

    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

Secondary outcomes

  1. Delivery of prescription or administration of antibiotics

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

    Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center

Acronym: FluProcess

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2016
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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