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Not yet recruiting NCT06700577

Multidrug Resistance in Newly Diagnosed TB Patient

Observational Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gene expert, Ultra xpert and xdr xpert.
Who it may be relevant to
Registry conditions: Tuberculosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Diagnostic test Gene expert
    Gene expert and XDR to detect multidrug resistance between tb patient
  • Genetic Ultra xpert and xdr xpert
    Detect resistance between tyberculous patient

Primary outcome measures

  • To detect the prevalence of multidrug resistant tuberculosis in newly diagnosed cases by xpert XDR assay. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\* previously treated patient

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Seung KJ, Keshavjee S, Rich ML. Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. Cold Spring Harb Perspect Med. 2015 Apr 27;5(9):a017863. doi: 10.1101/cshperspect.a017863. PMID 25918181

Identifiers

NCT: NCT06700577 · Gene expert and Tuberculosis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗