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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Genetic: xpert MTB , XDR assay

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

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Mohamed Esmat; Phone Number: 01064780592; Email: drmhmddr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory symptoms suggestive of pulmonary T.B like productive cough for >3 weeks, cough of any duration accompanied by constitutional symptoms (fever for at least 3 days, night sweats or weight loss of at least 3 kg in the previous month), or hemoptysis with radiological finding suggestive of pulmonary tb

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2024
• Primary Completion (Estimated): April 23, 2025
• Study Completion (Estimated): May 23, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: Pulmonary Tuberculosis xpert

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No