Clinical trial NCT03840603: Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Official title: PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Respiratory Tract Infections
Emergency Department
Procalcitonin
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
Collaborators: name: APHP
name: BioFortis
First posted: 2019-02-15
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Duration of total antibiotic exposure
timeFrame: First 28 days
Secondary outcomes:
measure: Initiation of an antibiotic therapy
timeFrame: First 28 days
measure: Protocol "failure" within 15 days of randomization
timeFrame: within 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Pitié la salpétrière
Study officials:
affiliation: Hôpital Pitié-Salpêtrière, APHP
name: Pierre Hausfater
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x.