NCT03840603

Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department

PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: BioMérieux · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Film Array RP2 Assay guided	Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-09-01
• Completion: 2022-11-01
• First posted: 2019-02-15
• Last updated: 2025-01-31

Locations

1 site across 1 country: France