Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654076
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None