Respiratory Tract InfectionsPROARRAYNCT03840603

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

A study testing Film Array RP2 Assay guided in people with Respiratory Tract Infections, run by BioMérieux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Tract Infections
What is being tested?: Film Array RP2 Assay guided
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 444 participants
Where: 1 siteFrance
Study dates: 1 Sep 2019to 1 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. 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.
2. Subject signs informed consent

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

France1 site

AP-HP Pitié la salpétrière
Paris

Other trials in France

About this study

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

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.

Read the 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:

PCT<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative FilmArray assay or
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.

Conditions: Respiratory Tract Infections
Being tested: Film Array RP2 Assay guided
Keywords: Respiratory Tract Infections, Emergency Department, Procalcitonin
Medical subject headings: Respiratory Tract Infections, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Film Array RP2 Assay guidedDiagnostic 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.

Study groups in NCT03840603
Study group	Role	What they receive
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. Receives: Diagnostic Test: Film Array RP2 Assay guided

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: First 28 days

Secondary outcomes (2)

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)
Measured: First 28 days
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)
Measured: within 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20191 Nov 2022

First posted15 Feb 2019
Study start1 Sep 2019
Primary completion1 Sep 2019
Study completion1 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).
Masking: Single blind
Who is masked: Participant
Enrolment: 444 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03840603
Sponsor's protocol ID: 2018-A02173-52
Acronym: PROARRAY
Status last verified: Jan 2025
First submitted: 12 Feb 2019
Last updated: 31 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22782201
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.
PubMed 25910632
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.
PubMed 25704448
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.
PubMed 21951385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
ClinicalTrials.gov ID: NCT03840603
Acronym / sponsor ID: PROARRAY / 2018-A02173-52
Conditions: Respiratory Tract Infections
Keywords: Respiratory Tract Infections, Emergency Department, Procalcitonin
Study type: Interventional
Recruitment status: Completed
Enrolment: 444 participants (actual)
Lead sponsor: BioMérieuxIndustry (pharma, biotech, devices)
Collaborators: APHP, BioFortis
Study start: 1 Sep 2019 (actual)
Primary completion: 1 Sep 2019 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 15 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Both results will be reported in real-time to the treating physicians with the recommendation to withhold or withdraw antibiotics if:

PCT<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative FilmArray assay or
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 design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).

Arm	Type	Receives
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	Diagnostic Test: Film Array RP2 Assay guidedIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Film Array RP2 Assay guidedNasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.	Diagnostic test	Film Array RP2 Assay guided

Primary outcome

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.

2 secondary outcomes

Initiation of an antibiotic therapy
Time frame: First 28 days
Protocol "failure" within 15 days of randomization
Time frame: within 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Background: PubMed 22782201Albrich 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.
Background: PubMed 25910632Branche 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.
Background: PubMed 25704448Das 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.
Background: PubMed 21951385Woodhead 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre Hausfater principal investigator

Hôpital Pitié-Salpêtrière, APHP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Film Array RP2 Assay guided in people with Respiratory Tract Infections, run by BioMérieux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of total antibiotic exposure (time frame: First 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840603, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.