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

8 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Maria Helena Rigatto, MD, PhD
  • Numero di telefono: +55 51 33597759
  • Email: mrigatto@hcpa.edu.br

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Group
Patients will undergo respiratory sample culture using conventional methods, as requested by the treating physician.
Sperimentale: Biofire arm
Patients will undergo BIOFIRE® FILMARRAY® testing on respiratory samples, in addition to conventional culture requested by the treating physician.
Test diagnostico: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adequacy of antimicrobial prescriptions using the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT).
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of days in under-treatment and/or overtreatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 30 days
Comparison of 30-day mortality rates between the intervention and control arms.
30 days
Clinical outcomes from Desirability of Outcome Ranking (DOOR)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaboratori

BioMérieux

Investigatori

  • Investigatore principale: Maria Helena Rigatto, MD, PhD, Hospital De Clinicas De Porto Alegre

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

2 maggio 2026

Completamento primario (Stimato)

2 maggio 2027

Completamento dello studio (Stimato)

2 giugno 2027

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-0408

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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