Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-11 @ 5:17 AM
Study NCT ID:
NCT03271567
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2017-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Detection of Circulating Mycobacterium Tuberculosis Antigen Peptides for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and molecular techniques, which have limitations including low sensitivity and high cost.Highly sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to the School of Biological and Health Systems Engineering, Arizona State University, for detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations, including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass spectrometry (MS) assay will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: