Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation

NCT05960383 | Unknown FDA Device

• 1 other identifier: 665_2022bis
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Transplant Infection; Molecular Diagnostic; Bacterial Infections; Pneumonia; Tracheobronchitis

Keywords

Lung transplant; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• microbiological concordance on recipient's BAL

  2023-2024

• concordance in in detecting molecular resistance patterns

  2023-2024

• difference in time to microbiological results

  2023-2024

• determine time to clinical decision

  2023-2024

Study Arms (1)

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

Interventions

BioFire Pneumonia Panel Plus DIAGNOSTIC_TEST

Assessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation

Lung transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all patients aged \>18 years that undergo lung transplantation from February 2023, at IRCCS Fondazione Cà Granda Policlinico in Milan and performed FBS+BAL

Sponsors & Collaborators

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

Study Sites (1)

Irccs Fondazione Ca' Granda Policlinico Di Milano

Milan, 20155, Italy

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Pneumonia; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Valeria Pastore

CONTACT

00390255034770; valeria.pastore@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: February 2, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)