Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Respiratory Tract Infections
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).Masking: Single (Participant)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 mult...
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: PCT<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative FilmArray assay or 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.
Tracking Information
- NCT #
- NCT03840603
- Collaborators
- APHP
- BioFortis
- Investigators
- Principal Investigator: Pierre Hausfater Hôpital Pitié-Salpêtrière, APHP