Respiratory Tract Infections Clinical Trial
Official title:
PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
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.
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