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

8 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control Group
Patients will undergo respiratory sample culture using conventional methods, as requested by the treating physician.
Experimenteel: Biofire arm
Patients will undergo BIOFIRE® FILMARRAY® testing on respiratory samples, in addition to conventional culture requested by the treating physician.
Diagnostische toets: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adequacy of antimicrobial prescriptions using the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT).
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of days in under-treatment and/or overtreatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 30 days
Comparison of 30-day mortality rates between the intervention and control arms.
30 days
Clinical outcomes from Desirability of Outcome Ranking (DOOR)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Clinicas de Porto Alegre

Medewerkers

BioMérieux

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

2 mei 2026

Primaire voltooiing (Geschat)

2 mei 2027

Studie voltooiing (Geschat)

2 juni 2027

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

8 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024-0408

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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