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NCT05960383 Clinical Trial

Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation

Pneumonia Clinical Trial

— PNEUMOARRAY  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05960383
Other study ID # 665_2022bis
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date November 1, 2024

Study information
Verified date July 2023
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Valeria Pastore
Phone 00390255034770
Email valeria.pastore@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 53
Est. completion date November 1, 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• BioFire Pneumonia Panel Plus
Assessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation

Locations
Country Name City State
Italy Irccs Fondazione Ca' Granda Policlinico Di Milano Milano

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary difference in time to microbiological results determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques 2023-2024
Secondary determine time to clinical decision determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques 2023-2024
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