Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Pneumocystis Jirovecii Pneumonia; Invasive Pulmonary Aspergillosis; Invasive Fungal Disease; Lung Transplant Recipients

Study type: Observational

Funder types: Other

Identifiers

NCT06654076

GS001

Details and patient eligibility

About

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.

Full 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

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.