Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 3:14 AM
Study NCT ID:
NCT03840603
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Sponsor:
BioMérieux
Organization:
Study Overview
Official Title:
PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROARRAY
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: