Status:
COMPLETED
Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Lead Sponsor:
BioMérieux
Collaborating Sponsors:
APHP
BioFortis
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 meas...
Eligibility Criteria
Inclusion
- 1\. Subject is ≥ 18 years of age attending the ED with LRTI symptom defined as at least one among:
- sweats, chills, body aches and pain, temperature \>38°C) and at least one among:
- cough, sputum production, dyspnea, chest pain, altered breath sounds at auscultation.
- 2\. Subject signs informed consent
Exclusion
- Subject is a prisoner
- Subject is a Pregnant
- Subject has no social insurance
- Subject is enrolled in end of life care
- Subject refuses to participate in study procedures
- Subject is already enrolled (each patient will only be tested one time with the FilmArray® RP2plus)
- Subject has a contraindication (per the discretion of the attending physician) to a nasopharyngeal swab (for example, nose bone fracture or recent history of maxilla-facial surgery)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT03840603
Start Date
September 1 2019
End Date
November 1 2022
Last Update
January 31 2025
Active Locations (1)
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1
AP-HP Pitié la salpétrière
Paris, France