An interventional study of Core Lab Test and ED Point of Care Test in Influenza-Like Illness and Influenza, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Diagnostic
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 233 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
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
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
Time frame: By the End of the ED visit (an average time of 4 hours)
Delivery of prescription or administration of antibiotics
Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD
Time frame: by the end of ED visit (an average time of 4 hours)
Plan to share: No
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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