NCT06654076

Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Invasive Fungal Disease
• Lung Transplant Recipients
• Invasive Pulmonary Aspergillosis
• Pneumocystis Jirovecii Pneumonia

Timeline

• Start date: 2015-01-01
• Primary completion: 2023-04-30
• Completion: 2024-08-01
• First posted: 2024-10-23
• Last updated: 2024-11-12