Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

NCT06654076 | Completed

• 1 other identifier: GS001
• Study Type: observational
• Target: 109
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia

  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.

  From January 2015 to April 2023

Secondary Outcomes (1)

• Comparison of Diagnostic Accuracy between mNGS and Other Methods

  From January 2015 to April 2023.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lung transplantation and were suspected of having invasive fungal infections (IPA or PJP) based on clinical symptoms, radiological findings, or microbiological results. The study includes adults aged 18 and above who were treated at a tertiary hospital from January 2015 to April 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens used in this study were bronchoalveolar lavage fluid (BALF) samples, collected from lung transplant recipients. These samples were used for diagnostic testing, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan (GM) assay, and lateral-flow device (LFD) tests, to evaluate invasive fungal disease. No DNA retention for future use is applicable.

MeSH Terms

Conditions

Invasive Fungal Infections; Invasive Pulmonary Aspergillosis; Pneumonia, Pneumocystis; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Pulmonary Aspergillosis; Aspergillosis; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: January 1, 2015
• Primary Completion: April 30, 2023
• Study Completion: August 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11