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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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06392594
Enrollment
46
Registered
2024-04-30
Start date
2024-04-23
Completion date
2025-05-23
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pulmonary

Brief summary

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

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

Interventions

GENETICxpert MTB , XDR assay

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
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 /RIFbaselineAll 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

Secondary

MeasureTime frameDescription
To assess the frequency of Xpert Ultra trace positive results . to investigate the effect of smear positive and smear negative on test accuracybaselineto know the accuracy of gene xpert in related to sputum sample of acid fast bacilli

Contacts

Primary ContactMohamed Esmat
drmhmddr@gmail.com01064780592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026