Multidrug Resistance in Newly Diagnosed TB Patient

Not yet recruiting

• Conditions: Tuberculosis

• Registration Number: NCT06700577
• Lead Sponsor: Assiut University

Brief Summary

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.

Multi drug-resistant Mycobacterium tuberculosis (MDR-TB) is one of the leading causes of death in the world.

The resource constraints make it difficult to diagnose and monitor the cases of MDR-TB.

GeneXpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe 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 1.1% 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 The main causes of the spread of resistant TB are weak medical Systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. Although patients harboring MDR and XDR strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

Detailed Description

To detect the prevalence of MDR T.B. using xpert MTB/RIF ultra and XDR assay in newly diagnosed cases

Study Timeline

• Study First Submitted: 2024-09-14
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

* previously treated patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To detect the prevalence of multidrug resistant tuberculosis in newly diagnosed cases by xpert XDR assay.	Baseline