Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
Performance of Xpert MTBRIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Performance of Xpert MTBRIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
To determine how accurate Xpert MTBRIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance
Detailed Description:
Tuberculosis TB is one of the major public health threats competing with the human immunodeficiency virus HIV as the cause of death due to infectious diseases worldwide
Tuberculosis TB is the leading cause of death by a single pathogen worldwide In 2019 12 million people died from TB among HIV-negative patients 208 000 among HIV-positive patients and 10 million were estimated to have fallen sick although only 70 were diagnosed The gap between TB notifications and estimated existing cases is still unacceptable The low TB case detection rate in many high-burden settings urgently demands effective strategies and tools to identify TB patients and ensure their linkage to healthcare
MDR Multidrug-resistant tuberculosis MDR-TB caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs
According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates the median prevalence of MDR-TB has been 11 in newly diagnosed patients The proportion however is considerably higher median prevalence 7 in patients who have previously received anti-TB treatment
XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin which defines MDR tuberculosis in addition to any fluoroquinolone and at least one of the three following injectable drugs capreomycin kanamycin and amikacin
Tuberculosis TB is the leading cause of death by a single pathogen worldwide In 2019 12 million people died from TB among HIV-negative patients 208 000 among HIV-positive patients and 10 million were estimated to have fallen sick although only 70 were diagnosed The gap between TB notifications and estimated existing cases is still unacceptable The low TB case detection rate in many high-burden settings urgently demands effective strategies and tools to identify TB patients and ensure their linkage to healthcare
MDR Multidrug-resistant tuberculosis MDR-TB caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs
According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates the median prevalence of MDR-TB has been 11 in newly diagnosed patients The proportion however is considerably higher median prevalence 7 in patients who have previously received anti-TB treatment
XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin which defines MDR tuberculosis in addition to any fluoroquinolone and at least one of the three following injectable drugs capreomycin kanamycin and amikacin
Study Oversight
Has Oversight DMC:
None
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?:
None