Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation (PNEUMOARRAY)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Bacterial Infections; Lung Transplant Infection; Tracheobronchitis; Molecular Diagnostic
• Intervention / Treatment: Diagnostic test: BioFire Pneumonia Panel Plus

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.

• Study Type: Observational
• Enrollment (Estimated): 53

Contacts and Locations

• Study Contact: Name: Valeria Pastore; Phone Number: 00390255034770; Email: valeria.pastore@policlinico.mi.it

Study Locations

• Italy
  • Milano, Italy, 20155
    • Recruiting
    • Irccs Fondazione Ca' Granda Policlinico Di Milano
    • Contact: Alessandra Bandera, Professor; Phone Number: 00390255034770; Email: alessandra.bandera@unimi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplant patients; 53 patients who receive lung transplant and undergo microbiologic assessment with BioFire Pneumonia Panel Plus and conventional culture	Diagnostic test: BioFire Pneumonia Panel Plus; Assessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Infection; Lung transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Pneumonia; Bacterial Infections
• Other Study ID Numbers: 665_2022bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes