Clinical trial NCT05960383: Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplant Infection
Molecular Diagnostic
Bacterial Infections
Pneumonia
Tracheobronchitis
Keywords: Lung transplant
Infection
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PNEUMOARRAY is a prospective study, including all patients aged \>18 years that undergo lung transplantation from February 2023, at IRCCS Fondazione Cà Granda Policlinico in Milan. Patients who do not meet inclusion criteria are excluded from this study.

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: microbiological concordance on donor's BAL
timeFrame: 2023-2024
Secondary outcomes:
measure: microbiological concordance on recipient's BAL
timeFrame: 2023-2024
measure: concordance in in detecting molecular resistance patterns
timeFrame: 2023-2024
measure: difference in time to microbiological results
timeFrame: 2023-2024
measure: determine time to clinical decision
timeFrame: 2023-2024
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Fondazione Ca' Granda Policlinico Di Milano
Study officials:
References: