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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06654076

Enrollment

109

Registered

2024-10-23

Start date

2015-01-01

Completion date

2024-08-01

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mNGS, Real-time PCR, Galactomannan Assay, Lateral-flow Device, Bronchoalveolar Lavage Fluid, Diagnostic Methods, Lung Transplantation, Fungal Infection

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results