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Not Yet Recruiting

NCT Number: NCT06700577

Multidrug Resistance in Newly Diagnosed TB Patient

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed tuberculosis patient
  • Diagnosed by direct smear for sputum or body fluid

Exclusion criteria

  • previously treated patient

Treatment and study plan

Gene expert

Diagnostic Test

Gene expert and XDR to detect multidrug resistance between tb patient

Ultra xpert and xdr xpert

Genetic

Detect resistance between tyberculous patient

Primary outcomes

  1. To detect the prevalence of multidrug resistant tuberculosis in newly diagnosed cases by xpert XDR assay.

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Nashat esmail zyada Resident doctor

CONTACT

[email protected]

0201033865906

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prevalence of Multidrug Resistant Tuberculosis by Xpert MTB/RIF Ultra and Xpert XDR Assay Among Newly Diagnosed Cases

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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