Impact of BioFire FilmArray Pneumonia Panel vs Routine Diagnostics on Antimicrobial Outcomes (DOOR-MAT)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Maria Helena Rigatto, MD, PhD
- Número de telefone: +55 51 33597759
- E-mail: mrigatto@hcpa.edu.br
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control Group
Patients will undergo respiratory sample culture using conventional methods, as requested by the treating physician.
|
|
|
Experimental: Biofire arm
Patients will undergo BIOFIRE® FILMARRAY® testing on respiratory samples, in addition to conventional culture requested by the treating physician.
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adequacy of antimicrobial prescriptions using the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT).
Prazo: 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. :
|
24 hours after the sample receipt in the microbiology laboratory
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of days in under-treatment and/or overtreatment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 30 days
|
Comparison of 30-day mortality rates between the intervention and control arms.
|
30 days
|
|
Clinical outcomes from Desirability of Outcome Ranking (DOOR)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria Helena Rigatto, MD, PhD, Hospital De Clinicas De Porto Alegre
Publicações e links úteis
Publicações Gerais
- Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D, Chuang-Stein C, Cosgrove SE, Fowler VG Jr, Lautenbach E, Chambers HF. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis. 2015 Sep 1;61(5):800-6. doi: 10.1093/cid/civ495. Epub 2015 Jun 25.
- Wilson BM, Jiang Y, Jump RLP, Viau RA, Perez F, Bonomo RA, Evans SR. Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR MAT): A Framework for Assessing Antibiotic Selection Strategies in the Presence of Drug Resistance. Clin Infect Dis. 2021 Jul 15;73(2):344-350. doi: 10.1093/cid/ciaa1769.
- Howard-Anderson J, Hamasaki T, Dai W, Collyar D, Rubin D, Nambiar S, Kinamon T, Leister-Tebbe H, Hill C, Geres H, Holland TL, Doernberg SB, Chambers HF, Fowler VG Jr, Evans SR, Boucher HW; Antibacterial Resistance Leadership Group. Moving Beyond Mortality: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia. Clin Infect Dis. 2024 Feb 17;78(2):259-268. doi: 10.1093/cid/ciad576.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Atributos da doença
- Infecções do Trato Respiratório
- Infecções
- Doenças Respiratórias
- Doenças pulmonares
- Pneumonia
- Infecções bacterianas
- Infecções Bacterianas e Micoses
- Infecção cruzada
- Doença Iatrogênica
- Condições Patológicas, Sinais e Sintomas
- Pneumonia associada à assistência à saúde
- Pneumonia Associada à Ventilação
- Pneumonia Bacteriana
Outros números de identificação do estudo
- 2024-0408
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Multiplex PCR-based pneumonia panel (BIOFIRE® FILMARRAY® Pneumonia Panel)
-
Assistance Publique - Hôpitaux de ParisConcluídoInfecções Graves Pneumonia com Ventilação Invasiva em UTIPFrança