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

RecruitingNAAges 18 Years - anyAllHospital de Clinicas de Porto Alegre
NCT07585604 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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