Clinical trial NCT06654076: Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients
Official title: Evaluating Ultra-Sensitive mNGS, Real-Time PCR, Galactomannan, and Lateral-Flow Device for Diagnosing Invasive Fungal Disease in Lung Transplantation: A Retrospective Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Disease
Lung Transplant Recipients
Invasive Pulmonary Aspergillosis
Pneumocystis Jirovecii Pneumonia
Keywords: mNGS
Real-time PCR
Galactomannan Assay
Lateral-flow Device
Bronchoalveolar Lavage Fluid
Diagnostic Methods
Lung Transplantation
Fungal Infection
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent lung transplantation and were suspected of having invasive fungal infections (IPA or PJP) based on clinical symptoms, radiological findings, or microbiological results. The study includes adults aged 18 and above who were treated at a tertiary hospital from January 2015 to April 2023.

Brief 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.

Detailed description: This retrospective, cross-sectional study evaluates the diagnostic accuracy of various tests in detecting invasive fungal disease (IFD) in lung transplant recipients. The diagnostic methods under assessment include metagenomic next-generation sequencing (mNGS), real-time polymerase chain reaction (PCR), galactomannan (GM) assay, and lateral-flow device (LFD) testing, all performed on bronchoalveolar lavage fluid (BALF) samples. The study analyzes the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method for diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP). The sample cohort consists of 109 lung transplant recipients, with data collected from January 2015 to April 2023

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia
timeFrame: From January 2015 to April 2023
Secondary outcomes:
measure: Comparison of Diagnostic Accuracy between mNGS and Other Methods
timeFrame: From January 2015 to April 2023.
Other outcomes:
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