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Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05960383
Acronym
PNEUMOARRAY
Enrollment
53
Registered
2023-07-25
Start date
2023-02-02
Completion date
2024-11-01
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lung transplant, Infection

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.

Interventions

DIAGNOSTIC_TESTBioFire Pneumonia Panel Plus

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

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
microbiological concordance on donor's BAL2023-2024determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation

Secondary

MeasureTime frameDescription
microbiological concordance on recipient's BAL2023-2024determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation
concordance in in detecting molecular resistance patterns2023-2024determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns
difference in time to microbiological results2023-2024determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques
determine time to clinical decision2023-2024determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques

Countries

Italy

Contacts

Primary ContactValeria Pastore
valeria.pastore@policlinico.mi.it00390255034770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026