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

July 1, 2020 updated by: BioMérieux

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Recruiting
        • AP-HP Pitié la salpétrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
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
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
Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of total antibiotic exposure
Time Frame: 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.
First 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiation of an antibiotic therapy
Time Frame: 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)
First 28 days
Protocol "failure" within 15 days of randomization
Time Frame: 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)
within 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMérieux

Collaborators

BioFortis
APHP

Investigators

  • Principal Investigator: Pierre Hausfater, Hôpital Pitié-Salpêtrière, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02173-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Tract Infections

Clinical Trials on Film Array RP2 Assay guided

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe