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

bioMérieux

Status: Completed

Conditions: Respiratory Tract Infections

Treatments: Diagnostic Test: Film Array RP2 Assay guided

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03840603

2018-A02173-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Subject is ≥ 18 years of age attending the ED with LRTI symptom defined as at least one among:

  2. sweats, chills, body aches and pain, temperature >38°C) and at least one among:

  3. 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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444 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Film Array RP2 Assay guided

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Film Array RP2 Assay guided