Rapid Testing for Upper Respiratory Tract Infection
(PROTECT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for infections rather than changing your current treatment.
What data supports the effectiveness of the treatment BIOFIRE® SPOTFIRE® Respiratory (R) Panel for upper respiratory tract infections?
Is the BIOFIRE® SPOTFIRE® Respiratory Panel safe for humans?
What is the purpose of this trial?
The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs).The study will use the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device, which is FDA-cleared and CLIA-Waived. This panel can identify up to 15 different viruses and bacteria that can cause URIs.These POC devices will be installed in primary care clinics within the University of Pennsylvania Health System. Patients who come to the clinic with cold-like symptoms (runny nose, cough) will be offered the test. If the patient agrees to the test, their clinician will use a swab to take a small sample of fluid from their nose. This swab will then be tested within the POC device and results will be available within 15 minutes.The results of this sample will be shared with the patient, and their clinician can use the results to help decide the most appropriate medical treatment for the patient.Patients who agree to take the test will be asked to answer a short survey about the test and their experience. Clinicians will also be surveyed to share their thoughts with using the test in their clinics. Focus groups of practice staff and clinicians will also be conducted to understand any potential challenges for using this test in practice.Results from the tests and the surveys will help researchers understand the value of the test to support antibiotic stewardship efforts in primary care clinic settings.
Eligibility Criteria
This trial is for adults over 18 with symptoms of an upper respiratory infection, such as cough, runny nose, nasal congestion, fever, sore throat or ear pain. It aims to improve how primary care doctors diagnose and treat these common illnesses.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implementation
Implementation of POC respiratory pathogen testing in primary care practices, including focus groups and surveys of clinicians
Intervention
Pragmatic, stepped-wedge, cluster randomized trial to study the impact of POC testing on antibiotic prescribing
Follow-up
Participants are monitored for healthcare utilization and prescription patterns after the index visit
Treatment Details
Interventions
- BIOFIRE® SPOTFIRE® Respiratory (R) Panel
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor