NCT06392594

Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB

Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

To determine how accurate Xpert MTB/RIF 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, 1.2 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 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

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
GENETIC	xpert MTB , XDR assay	To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

Timeline

• Start date: 2024-04-23
• Primary completion: 2025-04-23
• Completion: 2025-05-23
• First posted: 2024-04-30
• Last updated: 2024-04-30