Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

mNGSReal-time PCRGalactomannan AssayLateral-flow DeviceBronchoalveolar Lavage FluidDiagnostic MethodsLung TransplantationFungal 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

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Guangzhou Institute of Respiratory Disease
Otherlead

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 InfectionsInvasive Pulmonary AspergillosisPneumonia, PneumocystisMycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsPulmonary AspergillosisAspergillosisLung Diseases, FungalLung DiseasesRespiratory Tract DiseasesPneumocystis InfectionsRespiratory Tract InfectionsPneumonia

Enrollment

109 participants (actual enrollment reported by the registry).

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

Actual (reported)

Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record