The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05960383
Recruitment Status : Recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Lung Transplant Infection Molecular Diagnostic Bacterial Infections Pneumonia Tracheobronchitis 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 2, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. microbiological concordance on donor's BAL [ Time Frame: 2023-2024 ]
    determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation


Secondary Outcome Measures :
  1. microbiological concordance on recipient's BAL [ Time Frame: 2023-2024 ]
    determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation

  2. concordance in in detecting molecular resistance patterns [ Time Frame: 2023-2024 ]
    determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns

  3. difference in time to microbiological results [ Time Frame: 2023-2024 ]
    determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques

  4. determine time to clinical decision [ Time Frame: 2023-2024 ]
    determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05960383


Contacts
Layout table for location contacts
Contact: Valeria Pastore 00390255034770 valeria.pastore@policlinico.mi.it

Locations
Layout table for location information
Italy
Irccs Fondazione Ca' Granda Policlinico Di Milano Recruiting
Milano, Italy, 20155
Contact: Alessandra Bandera, Professor    00390255034770    alessandra.bandera@unimi.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT05960383    
Other Study ID Numbers: 665_2022bis
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Layout table for additional information
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
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Lung transplant
Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Pneumonia
Bacterial Infections
Disease Attributes
 Pathologic Processes
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections and Mycoses