Lung Transplant InfectionPNEUMOARRAYNCT05960383
Molecular vs Conventional Microbiologic Diagnosis for Infections in Lung Transplantation
An observational study of Lung Transplant Infection and Molecular Diagnostic, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Infection, Molecular Diagnostic, Bacterial Infections
- What is being tested?
- BioFire Pneumonia Panel Plus
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all patients aged >18 years that undergo lung transplantation from February 2023, at IRCCS Fondazione Cà Granda Policlinico in Milan and performed FBS+BAL
Who cannot join
- Patients who do not meet inclusion criteria are excluded from this study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs Fondazione Ca' Granda Policlinico Di Milano
Milan, 20155
Alessandra Bandera, Professor, 00390255034770, alessandra.bandera@unimi.it
About this study
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
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
Read the 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.
- Conditions
- Lung Transplant Infection, Molecular Diagnostic, Bacterial Infections, Pneumonia, Tracheobronchitis
- Being tested
- BioFire Pneumonia Panel Plus
- Keywords
- Lung transplant, Infection
- Medical subject headings
- Bacterial Infections, Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFire Pneumonia Panel PlusDiagnostic test
Assessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant patients | 53 patients who receive lung transplant and undergo microbiologic assessment with BioFire Pneumonia Panel Plus and conventional culture Receives: Diagnostic Test: BioFire Pneumonia Panel Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2023-2024
Secondary outcomes (4)
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
Measured: 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
Measured: 2023-2024
difference in time to microbiological results
determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques
Measured: 2023-2024
determine time to clinical decision
determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques
Measured: 2023-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start2 Feb 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960383
- Sponsor's protocol ID
- 665_2022bis
- Acronym
- PNEUMOARRAY
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05960383
- Acronym / sponsor ID
- PNEUMOARRAY / 665_2022bis
- Conditions
- Lung Transplant Infection, Molecular Diagnostic, Bacterial Infections, Pneumonia, Tracheobronchitis
- Keywords
- Lung transplant, Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant patients | – | Diagnostic Test: BioFire Pneumonia Panel Plus53 patients who receive lung transplant and undergo microbiologic assessment with BioFire Pneumonia Panel Plus and conventional culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients aged >18 years that undergo lung transplantation from February 2023, at IRCCS Fondazione Cà Granda Policlinico in Milan and performed FBS+BAL
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria are excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFire Pneumonia Panel PlusAssessment of sensbility and specificity of BioFire Pneumonia Panel Plus in lung transplantation | Diagnostic test | Lung transplant patients |
Primary outcome
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
4 secondary outcomes
microbiological concordance on recipient's BAL
Time frame: 2023-2024
concordance in in detecting molecular resistance patterns
Time frame: 2023-2024
difference in time to microbiological results
Time frame: 2023-2024
determine time to clinical decision
Time frame: 2023-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Infection and Molecular Diagnostic, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Pastore (00390255034770, valeria.pastore@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiological concordance on donor's BAL (time frame: 2023-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.