Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation

Study Overview
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Brief Summary
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The goal of this prospective study is to compare rapid molecular technique BioFire Pneumonia Panel Filmarray and conventional culture-based methods in the microbiologic diagnosis on bronchoalveolar lavage of lung transplant patients. The main questions it aims to answer are: determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques

Detailed Description
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Molecular assays that detect bacterial organisms by nucleic acid sequences rather than culture have the potential to improve time to diagnosis for lower respiratory tract infections. However, their performance characteristics are unknown in lung transplant recipients. PNEUMOARRAY is a prospective study, including all patients aged >18 years that undergo lung transplantation from September 2022, at IRCCS Fondazione Cà Granda Policlinico in Milan. Patients who do not meet inclusion criteria are excluded from this study. A fibro-bronchoscopy (FBS) with bronchoalveolar lavage (BAL) is performed, according to clinical practice, both on lungs donor and recipient. Donor's BAL is collected before graft transplantation, while BAL on lung transplant recipient is performed 72 hours after transplantation. On each BAL sample, both of lung donor and recipient, molecular diagnostic and culture exam are performed. The goal of this prospective study is to compare rapid molecular technique BioFire Pneumonia Panel Filamarray and conventional culture-based methods in the microbiological diagnosis on bronchoalveolar lavage of lung transplant patients. The primary outcome is: -determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation Secondary outcomes are: determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques Sample size for statistical significance includes 53 patients. For the majority of bacteria and fungi, microbiological culture from BAL remains the gold standard for diagnosis, but cultures are limited by long turnaround time and decreased sensitivity in patients that have received empiric anti-infective therapy. In this setting, fast microbiological diagnosis may be crucial to begin targeted antimicrobial therapy/prophylaxis and identify genes encoding resistance, in order to administer targeted therapy and to reduce antimicrobial resistance.

Official Title
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Comparison Between Rapid Molecular Technique BioFire Pneumonia Panel Filmarray and Conventional Culture-based Methods in the Microbiologic Diagnosis on Bronchoalveolar Lavage Fluid of Lung Transplant Patients

Conditions
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Lung Transplant Infection, Molecular Diagnostic, Bacterial Infections, Pneumonia, Tracheobronchitis

Intervention / Treatment
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* Diagnostic Test: BioFire Pneumonia Panel Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients aged >18 years that undergo lung transplantation from February 2023, at IRCCS Fondazione Cà Granda Policlinico in Milan and performed FBS+BAL Exclusion Criteria: Patients who do not meet inclusion criteria are excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung transplant patients<br>53 patients who receive lung transplant and undergo microbiologic assessment with BioFire Pneumonia Panel Plus and conventional culture | Diagnostic Test: BioFire Pneumonia Panel Plus<br>* Assessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological concordance on donor's BAL | determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation | 2023-2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological concordance on recipient's BAL | determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation | 2023-2024 | 
| concordance in in detecting molecular resistance patterns | determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns | 2023-2024 | 
| difference in time to microbiological results | determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques | 2023-2024 | 
| determine time to clinical decision | determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques | 2023-2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung transplant, Infection