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

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392594
• Other study ID #: Pulmonary Tuberculosis xpert
• Status: Not yet recruiting
• Start date: April 23, 2024
• Est. completion date: May 23, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Mohamed Esmat
• Phone: 01064780592
• Email: drmhmddr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: May 23, 2025
• Est. primary completion date: April 23, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Patients with respiratory symptoms suggestive of pulmonary T.B 2. Patients who were able to collect a sputum sample were included in the study 3. Patients with positive xpert MTB/RIF for XDR assay

Exclusion Criteria:

• Patients who were unable to collect a sputum sample Patient with negative xpert MTB/RIF for XDR assay Patients with extrapulmonary tb Patients with positive culture for MOTT

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Genetic:
• xpert MTB , XDR assay
To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detect the performance of xpert MTB/RIF for detection of pulmonary tuberculosis and detection of rifampicin resistant • to detect the diagnostic accuracy of XDR in diagnosis of INH and rifampicin resistance in positive cases of xpert MTB /RIF	All Patients with respiratory symptoms suggestive of pulmonary TB will go for • Sputum for; acid fast bacilli; culture (the gold standard ); Gene xpert or ultra expert; XDR (For positive gene xpert or ultra xpert to detect the accuracy of gene xpert in diagnosis of pulmonary tuberculosios and rifampicin resistant	baseline
Secondary	To assess the frequency of Xpert Ultra trace positive results . to investigate the effect of smear positive and smear negative on test accuracy	to know the accuracy of gene xpert in related to sputum sample of acid fast bacilli	baseline