Respiratory Tract Infections
Conditions
Keywords
Respiratory Tract Infections, Emergency Department, Procalcitonin
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.
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.
Interventions
DIAGNOSTIC_TESTFilm 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
APHP
BioFortis
BioMérieux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Subject is ≥ 18 years of age attending the ED with LRTI symptom defined as at least one among: 1. sweats, chills, body aches and pain, temperature \>38°C) and at least one among: 2. cough, sputum production, dyspnea, chest pain, altered breath sounds at auscultation. * 2\. Subject signs informed consent
Exclusion criteria
1. Subject is a prisoner 2. Subject is a Pregnant 3. Subject has no social insurance 4. Subject is enrolled in end of life care 5. Subject refuses to participate in study procedures 6. Subject is already enrolled (each patient will only be tested one time with the FilmArray® RP2plus) 7. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of total antibiotic exposure | First 28 days | The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of an antibiotic therapy | First 28 days | 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) |
| Protocol failure within 15 days of randomization | within 15 days | 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) |
Countries
France
Outcome results
None listed