Multidrug Resistance in Newly Diagnosed TB Patient

NCT06700577 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Gene expert and Tuberculosis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All newly diagnosed TB patient above 18 years who not recieved antituberculus drug before

You may qualify if:

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

You may not qualify if:

• \* previously treated patient

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Fatma Nashat esmail zyada Resident doctor

CONTACT

0201033865906; nashatfatma209@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulomongist , principale investigator , Resident doctor

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11