The real-time reporting of PCT results along with viral PCR data from the FilmArray® Respiratory Panel 2 plus in conjunction with an antimicrobial stewardship plan will aid in the proper withholding or withdrawing of antibiotics (ATB) when the collective data is indicative of a viral Lower Respiratory Tract Infection (LRTI). The addition of the FilmArray® RP2plus diagnostic test indicating the presence of a viral infection in subjects presenting with respiratory symptoms could improve the confidence to care-providing physicians to withhold prescribing antibiotics.
In the emergency room a nasopharyngeal swab sample will be collected from subjects with a suspected LRTI for the FilmArray respiratory panel assay plus a blood sample for the PCT assay if the PCT measurement has not been already prescribed. The FilmArray® Respiratory Panel 2 plus (RP2plus) is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. Both results will be reported in real-time to the treating physicians with the recommendation to withhold or withdraw antibiotics if: 1. PCT\<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative FilmArray assay or 2. PCT\<0.25 µg/L and FilmArray positive with a viral respiratory pathogen. For the control arm, patients will benefit from the usual care of patients with suspected LRTI at the discretion of the attending physician. Care may entail a CRP and/or a PCT measurement, but no nasopharyngeal swab sampling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
444
Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.
AP-HP Pitié la salpétrière
Paris, France
Duration of total antibiotic exposure
The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization.
Time frame: First 28 days
Initiation of an antibiotic therapy
initiation of an antibiotic therapy in the first 28 days after the reporting test results to clinicians (both ATB given in the ED or given a prescription for an ATB to get at the pharmacy)
Time frame: First 28 days
Protocol "failure" within 15 days of randomization
protocol "failure" within 15 days of randomization (defined as worsening of LRTI and/or receipt of antibiotics in cases where no initial ATB treatment was administered, and/or unplanned ED's re-admission for the same complaint)
Time frame: within 15 days
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