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

Respiratory Tract Infections Clinical Trial

— PROARRAY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840603
• Other study ID #: 2018-A02173-52
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2020
• Source: BioMérieux
• Contact: Pierre Hausfater, Pr.
• Phone: 00 33 1 42 17 72 40
• Email: pierre.hausfater[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP Pitié la salpétrière	Paris

Sponsors (3)

Lead Sponsor	Collaborator
BioMérieux	APHP, BioFortis

Country where clinical trial is conducted

France, 

References & Publications (4)

Albrich WC, Dusemund F, Bucher B, Meyer S, Thomann R, Kühn 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. Erratum in: Arch Intern Med. 2014 Jun;174(6):1011. — View Citation

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. — View Citation

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. — View Citation

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:E1-59. doi: 10.1111/j.1469-0691.2011.03672.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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