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Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients | Clinical Trials | Clareo Health

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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

NCT06654076•Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

January 1, 2015

Primary Completion Date

April 30, 2023

Completion Date

August 1, 2024

Last Updated

November 12, 2024

Enrollment

109

ACTUAL participants

Conditions

Invasive Fungal DiseaseLung Transplant RecipientsInvasive Pulmonary AspergillosisPneumocystis Jirovecii Pneumonia

Influenza Associated Aspergillosis In-depth Investigation

NCT03748069

Influenza With PneumoniaInvasive Pulmonary Aspergillosis

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RECRUITING

Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726

LeukemiaLeukemia, Myeloid+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

Inclusion Criteria

Exclusion Criteria

Influenza Associated Aspergillosis In-depth Investigation

Breath Analysis for the Detection of Invasive Fungal Infections

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

De-escalation - Antifungal Treatment Immunocompromised Patients

The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation

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