Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

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.

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Key information

Conditions

Invasive Fungal Disease Aspergillosis Bacterial Infections and Mycoses Infections Invasive Fungal Infections Invasive Pulmonary Aspergillosis Lung Diseases Lung Diseases, Fungal Lung Transplant Recipients Mycoses Pneumocystis Infections Pneumocystis Jirovecii Pneumonia Pneumonia Pneumonia, Pneumocystis Pulmonary Aspergillosis Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia

Time frame: From January 2015 to April 2023

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of metagenomic next-generation sequencing (mNGS) in diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP) using bronchoalveolar lavage fluid (BALF) samples.

Secondary outcomes

Comparison of Diagnostic Accuracy between mNGS and Other Methods

Time frame: From January 2015 to April 2023.

Comparative analysis of diagnostic accuracy, including sensitivity and specificity, between mNGS, real-time PCR, Galactomannan (GM) assay, and lateral-flow device (LFD) tests for detecting IPA and PJP in lung transplant recipients.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2024
First posted: Oct 23, 2024
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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