Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

Completed

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

• Registration Number: NCT06654076
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2023-04-30
• Study Completion: 2024-08-01
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia	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 Outcome Measures

Name	Time	Method
Comparison of Diagnostic Accuracy between mNGS and Other Methods	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.