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Impact of BioFire FilmArray Pneumonia Panel vs Routine Diagnostics on Antimicrobial Outcomes (DOOR-MAT)

8. mai 2026 oppdatert av: Maria Helena Rigatto, Hospital de Clinicas de Porto Alegre

A Randomized Multicenter Clinical Trial Comparing BIOFIRE® FILMARRAY® Pneumonia (PN) Panels Versus Routine Diagnostic Methods in Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR MAT) in Hospitalized Patients With Lower Respiratory Tract Infections.

Multidrug-resistant bacterial infections are a growing global health concern. Hospital-acquired pneumonia is one of the most common infections occurring during hospitalization and can be associated with high mortality, reaching up to 50% in severe cases. One of the main reasons for poor outcomes is the delay in starting the most appropriate antibiotic treatment.

Standard laboratory methods used to identify the bacteria and determine which antibiotics are effective usually take between 48 and 96 hours to provide results. During this time, patients often receive broad-spectrum antibiotics, which may not be optimal and can contribute to antimicrobial resistance.

Rapid diagnostic tests, such as the BIOFIRE® FILMARRAY® Pneumonia Panel, can detect multiple bacteria and important resistance markers directly from respiratory samples in about one hour. These tests are already approved for use in Brazil and are easy to perform. Previous studies in patients with community-acquired pneumonia have shown that these rapid tests can help doctors choose more appropriate antibiotics earlier and may improve patient outcomes.

However, their benefit has not been well studied in patients with hospital-acquired pneumonia, especially in settings where multidrug-resistant bacteria are common. In these situations, early and appropriate adjustment of antibiotic therapy is particularly important for improving outcomes and ensuring the responsible use of advanced antibiotics.

This study aims to compare the use of rapid diagnostic panels with standard laboratory methods in hospitalized patients with suspected pneumonia. The main focus is to evaluate how quickly and how appropriately antibiotic treatment can be adjusted after sample collection, using a structured scoring system, the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy(DOOR-MAT), as well as to assess clinical outcomes.

The results of this study may help determine whether rapid diagnostic testing improves patient care in real-world hospital settings. The findings could support decision-making within the Brazilian Unified Health System (SUS) regarding the adoption of this technology, and may also contribute to future analyses of its cost-effectiveness.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years.
  • Clinical diagnosis of hospital-acquired pneumonia or clinically relevant tracheobronchitis requiring antimicrobial treatment, with or without mechanical ventilation.
  • No respiratory cultures collected in the last 72 hours (except for the culture that will potentially be evaluated in the study-trigger for inclusion).
  • Agreement from the patient or legal representative to sign the Informed Consent Form (ICF).

Exclusion Criteria:

  • Inadequate respiratory samples according to laboratory cutoffs for squamous epithelial cells and polymorphonuclear leukocytes (sputum or endotracheal aspirate).
  • Incarcerated populations.
  • Pregnant women.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control Group
Patients will undergo respiratory sample culture using conventional methods, as requested by the treating physician.
Eksperimentell: Biofire arm
Patients will undergo BIOFIRE® FILMARRAY® testing on respiratory samples, in addition to conventional culture requested by the treating physician.
Diagnostisk test: Multiplex PCR-based pneumonia panel (BIOFIRE® FILMARRAY® Pneumonia Panel)

The BIOFIRE® FILMARRAY® Pneumonia Panel is a rapid, automated molecular diagnostic test designed to detect a broad range of respiratory pathogens directly from lower respiratory tract samples, such as sputum, tracheal aspirates, or bronchoalveolar lavage. The system integrates sample preparation, nucleic acid extraction, amplification, and detection into a single, fully automated platform.

The test can identify multiple bacterial and viral pathogens, as well as key antimicrobial resistance genes, within approximately one hour. It provides semi-quantitative results for selected bacteria, which may help differentiate colonization from infection. The panel is designed for ease of use and requires minimal hands-on time.

By delivering rapid and comprehensive microbiological results, the BIOFIRE® FILMARRAY® Pneumonia Panel has the potential to support earlier optimization of antimicrobial therapy, improve clinical decision-making, and contribute to antimicrobial stewardship efforts, partic

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adequacy of antimicrobial prescriptions using the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT).
Tidsramme: 24 hours after the sample receipt in the microbiology laboratory

Adequacy of antimicrobial prescriptions using the following scoring system based on DOOR-MAT analysis within the first 24 hours after the sample receipt.

Antimicrobial therapy will be evaluated on the first day after inclusion and classified by two blinded infectious disease physicians according to the criteria described below. In case of disagreement, a third evaluator will adjudicate using the same criteria. :

  • Ideal treatment (most desirable): Preferred antibiotic, without unnecessary additional antimicrobials. 100 points.
  • Overtreatment: Preferred antibiotic + combination with unnecessary antimicrobials or active antimicrobials with a broader spectrum than necessary. 50 points.
  • Inactive or suboptimal treatment* (least desirable). 0 points. Patients with no diagnosis (negative culture and Biofire negative)-0 points. *Patients receiving active drugs in vitro, but not preferred in clinical practice.
24 hours after the sample receipt in the microbiology laboratory

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of days in under-treatment and/or overtreatment
Tidsramme: 7 days
Proportion of days in under-treatment and/or overtreatment during the first 7 days (D1-D7) after study inclusion and time to ideal therapy in both groups. DOOR - Response Adjusted for Duration of Antibiotic Risk (RADAR).
7 days
Simulated ideal Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) scores
Tidsramme: 24 hours
Antimicrobial prescription convenience scores on the first day, simulating these choices made by physicians following the BIOFIRE® FILMARRAY panels' results (ideal scores): - Ideal treatment (most desirable): Preferred antibiotic, without unnecessary additional antimicrobials. 100 points. - Overtreatment: Preferred antibiotic + combination with unnecessary antimicrobials or active antimicrobials with a broader spectrum than necessary. 50 points. - Inactive or suboptimal treatment* (least desirable). 0 points. Patients with no diagnosis (negative culture and Biofire negative)-0 points.
24 hours
Agreement between real Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) scores and ideal scores
Tidsramme: 24 hours
Agreement between real desirability DOOR-MAT scores and ideal scores considering the rapid test results were followed (this is only within the intervention arm): - Ideal treatment (most desirable): Preferred antibiotic, without unnecessary additional antimicrobials. 100 points. - Overtreatment: Preferred antibiotic + combination with unnecessary antimicrobials or active antimicrobials with a broader spectrum than necessary. 50 points. - Inactive or suboptimal treatment* (least desirable). 0 points. Patients with no diagnosis (negative culture and Biofire negative)-0 points.
24 hours
30-day mortality
Tidsramme: 30 days
Comparison of 30-day mortality rates between the intervention and control arms.
30 days
Clinical outcomes from Desirability of Outcome Ranking (DOOR)
Tidsramme: 2, 7 and 14 days
Clinical outcomes will be assessed using the DOOR at days 2, 7, and 14. Patients will be assigned a score from 1 (most desirable outcome) to 5 (least desirable outcome) based on the occurrence of the following events: (1) absence of clinical response, (2) infectious complications, and (3) serious adverse events. Patients who do not develop any of these events will be assigned a score of 1; those who develop one, two, or all three events will be assigned scores of 2, 3, and 4, respectively. Patients who die will be assigned a score of 5.
2, 7 and 14 days
Agreement between Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) and Clinical DOOR scores
Tidsramme: 14 days
Agreement between DOOR-MAT scores at 24 hours (desirability scale ranging from 0 [least desirable] to 100 [most desirable]) and clinical outcome scores at 14 days (ordinal scale ranging from 1 [most desirable] to 5 [least desirable]) will be evaluated in a two-dimensional space.
14 days
Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) scores in subgroups
Tidsramme: 24 hours
DOOR-MAT scores in subgroups with microbiologically confirmed infections, viral infections, gram-positive infections, gram-negative infections, and carbapenem-resistant gram-negative infections: - Ideal treatment (most desirable): Preferred antibiotic, without unnecessary additional antimicrobials. 100 points. - Overtreatment: Preferred antibiotic + combination with unnecessary antimicrobials or active antimicrobials with a broader spectrum than necessary. 50 points. - Inactive or suboptimal treatment* (least desirable). 0 points. Patients with no diagnosis (negative culture and Biofire negative)-0 points. *Patients receiving active drugs in vitro, but not preferred in clinical practice.
24 hours
Cost-effectiveness analysis
Tidsramme: through study completion, an average of 1 year
To compare cost-effectiveness between the BioFire arm and the control arm using retrospectively collected data from the hospital management system.
through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital de Clinicas de Porto Alegre

Samarbeidspartnere

BioMérieux

Etterforskere

  • Hovedetterforsker: Maria Helena Rigatto, MD, PhD, Hospital de Clínicas de Porto Alegre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. mai 2026

Primær fullføring (Antatt)

2. mai 2027

Studiet fullført (Antatt)

2. juni 2027

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024-0408

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) will be shared upon reasonable request. Data will be available to qualified researchers with methodologically sound proposals, subject to approval by the study investigators and compliance with institutional, ethical, and data protection regulations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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