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

NCT03840603 | Completed

• 1 other identifier: 2018-A02173-52
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

Respiratory Tract Infections; Emergency Department; Procalcitonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Initiation of an antibiotic therapy

  First 28 days

• Protocol "failure" within 15 days of randomization

  within 15 days

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Film Array RP2 Assay guided DIAGNOSTIC_TEST

Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.

Film Array RP2 Assay guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Subject signs informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• BioMérieux: lead
• APHP: collaborator
• BioFortis: collaborator

Study Sites (1)

AP-HP Pitié la salpétrière

Paris, France

Location

Related Publications (4)

• Albrich WC, Dusemund F, Bucher B, Meyer S, Thomann R, Kuhn F, Bassetti S, Sprenger M, Bachli E, Sigrist T, Schwietert M, Amin D, Hausfater P, Carre E, Gaillat J, Schuetz P, Regez K, Bossart R, Schild U, Mueller B; ProREAL Study Team. Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in "real life": an international, multicenter poststudy survey (ProREAL). Arch Intern Med. 2012 May 14;172(9):715-22. doi: 10.1001/archinternmed.2012.770.

  PMID: 22782201 BACKGROUND

• Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.

  PMID: 25910632 BACKGROUND

• Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.

  PMID: 25704448 BACKGROUND

• Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ; Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections--full version. Clin Microbiol Infect. 2011 Nov;17 Suppl 6(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x.

  PMID: 21951385 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Emergencies

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Hausfater

  Hôpital Pitié-Salpêtrière, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2022
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)