Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients (NCT06654076) | Clinical Trial Compass
CompletedNot Applicable
Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients
109 participantsStarted 2015-01-01
Plain-language summary
This study aims to assess the diagnostic performance of different tests, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan assay, and lateral-flow device tests, in detecting invasive fungal disease in lung transplant recipients using bronchoalveolar lavage fluid samples. The study is retrospective and cross-sectional in design.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult lung transplant recipients aged 18 years and older.
* Suspected cases of invasive fungal infection (invasive pulmonary aspergillosis or -Pneumocystis jirovecii pneumonia) based on clinical symptoms, radiological findings, or microbiological evidence.
* Able to provide sufficient bronchoalveolar lavage fluid (BALF) samples for diagnostic testing.
Exclusion Criteria:
* Patients with confirmed non-fungal infections.
* Patients unable to provide adequate BALF samples for analysis.
* Patients with severe comorbidities that prevent study participation or completion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already completed, has my doctor seen or reviewed its findings on whether metagenomic next-generation sequencing — mNGS — was more accurate than standard tests for diagnosing invasive pulmonary aspergillosis and Pneumocystis jirovecii pneumonia in lung transplant patients?
2Given that I'm a lung transplant recipient and these are exactly the fungal infections studied, should my care team be using mNGS testing as part of my monitoring or workup, and is that something available at this hospital based on what studies like this one have shown?
3How does mNGS compare to the conventional diagnostic methods my team currently uses — like cultures, bronchoscopy, or standard blood tests — when it comes to catching these infections early enough to make a real difference?
4Since Pneumocystis jirovecii pneumonia and invasive aspergillosis can both be serious after a lung transplant, how does my doctor currently decide which infection to test for first, and could findings from a study like this change that approach for my situation?
5Are there any practical barriers — like cost, availability, or turnaround time — to using mNGS-based testing that would prevent my care team from applying what this completed trial may have learned, even if the results support it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia