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

NCT03840603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2025-01-31

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infections

Interventions

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.

Sponsors & Collaborators

  • APHP

    collaborator OTHER

  • BioFortis

    collaborator OTHER

  • BioMérieux

    lead INDUSTRY

Principal Investigators

  • Pierre Hausfater · Hôpital Pitié-Salpêtrière, APHP

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-09-01
Completion
2022-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840603 on ClinicalTrials.gov