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

NCT07585604 | Not Yet Recruiting

• 1 other identifier: 2024-0408
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumonia - Bacterial

Keywords

BIOFIRE® FILMARRAY®; Hospital-acquired pneumonia; Ventilator-associated pneumonia; DOOR-MAT; Antimicrobial resistance; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Adequacy of antimicrobial prescriptions using the Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT).

  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

Secondary Outcomes (8)

• Proportion of days in under-treatment and/or overtreatment

  7 days

• Simulated ideal Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) scores

  24 hours

• Agreement between real Desirability of Outcome Ranking for the Management of Antimicrobial Therapy (DOOR-MAT) scores and ideal scores

  24 hours

• 30-day mortality

  30 days

• Clinical outcomes from Desirability of Outcome Ranking (DOOR)

  2, 7 and 14 days

Study Arms (2)

Control Group

NO INTERVENTION

Patients will undergo respiratory sample culture using conventional methods, as requested by the treating physician.

Biofire arm

EXPERIMENTAL

Patients will undergo BIOFIRE® FILMARRAY® testing on respiratory samples, in addition to conventional culture requested by the treating physician.

Diagnostic Test: Multiplex PCR-based pneumonia panel (BIOFIRE® FILMARRAY® Pneumonia Panel)

Interventions

Multiplex PCR-based pneumonia panel (BIOFIRE® FILMARRAY® Pneumonia Panel) DIAGNOSTIC_TEST

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

Biofire arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Clinical diagnosis of hospital-acquired pneumonia or clinically relevant tracheobronchitis requiring antimicrobial treatment, with or without mechanical ventilation.
• Agreement from the patient or legal representative to sign the Informed Consent Form (ICF).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• BioMérieux: collaborator

Related Publications (3)

• 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.

  PMID: 26113652 BACKGROUND

• 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.

  PMID: 33245333 BACKGROUND

• 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.

  PMID: 37740559 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Bacterial; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Helena Rigatto, MD, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Helena Rigatto, MD, PhD

CONTACT

+55 51 33597759; mrigatto@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 14, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share