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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Diagnostic Test: Film Array RP2 Assay guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care of patients with suspected Low RespiratoryTract Infection at the discretion of the attending physician. Care may entail a CRP and/or a PCT measurement, but no nasopharyngeal swab sampling. | |
| Experimental: Film Array RP2 Assay guided<br>In the emergency room a nasopharyngeal swab sample will be collected from subjects with a suspected Low RespiratoryTract Infection for the Film Array RP2 Assay guided plus a blood sample for the PCT assay if the PCT measurement has not been already prescribed. | Diagnostic Test: Film Array RP2 Assay guided<br>* Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of total antibiotic exposure | The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization. | First 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of an antibiotic therapy | initiation of an antibiotic therapy in the first 28 days after the reporting test results to clinicians (both ATB given in the ED or given a prescription for an ATB to get at the pharmacy) | First 28 days | 
| Protocol failure within 15 days of randomization | protocol failure within 15 days of randomization (defined as worsening of LRTI and/or receipt of antibiotics in cases where no initial ATB treatment was administered, and/or unplanned ED's re-admission for the same complaint) | within 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Tract Infections, Emergency Department, Procalcitonin