Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospitals

* Detection of sensitivity and specificity of microscopic examination and Molecular studies using polymerase chain reaction (PCR) Mycobacterium tuberculosis (MTB)/ non tuberculous mycobacterium (NTM) MDR-TB compared to culture which is the gold standard technique in the diagnosis of TB to reach the most reliable one for better health care service. * Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.

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Key information

Conditions

Tuberculosis Diagnosis

Sex eligibility

All sexes

Study type

Observational

About this study

Tuberculosis (TB) is an infectious disease of global public health importance caused by the M. tuberculosis complex. Alarmingly, the disease has worsened with the emergence of multidrug-resistant strains of tuberculosis (MDR-TB).

Annually, it is estimated that approximately 450,000 new cases of MDR-TB occur according to a report from 2021.

There is an alarming increase in the global incidence rate of tuberculosis in the year 2021 after covid-19 pandemic, reversing the downward trend maintained in previous decades. In parallel, there is a rise in cases of drug-resistant tuberculosis.

Early diagnosis and appropriate treatment of tuberculosis are essential public health priorities. In this context, microbiology laboratories play a vital role in the rapid and accurate detection of tuberculosis and drug resistance.

Accurate and prompt diagnosis of TB is essential for the control and management of the disease, but there are numerous factors that affect the effectiveness of this process. These problems include the difficulty of correctly diagnosing latent and active forms of TB, the lack of precise protocols for different types of TB, and the difficulty of accessing diagnostic facilities in regions with limited resources.

Laboratory diagnosis of pulmonary tuberculosis is essential in combating the disease, with a significant role in patient management and isolation of contagious cases. In many developing countries with a high incidence of TB, advanced diagnostic methods and drug susceptibility testing are rarely available.

Given its substantial influence on global health, it is imperative that the investigators continue researching and developing innovative techniques and technologies to better the detection and treatment of tuberculosis.

In our study, the investigators try to compare between different available tests to diagnose TB for better treatment and health care service.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with signs and symptoms of tuberculosis (suspected cases)
Patients diagnosed with tuberculosis.

Exclusion criteria

Patients with pulmonary infections other than TB

Treatment and study plan

PCR MTB/NTM

Diagnostic Test

The Polymerase chain reaction (PCR) MTB/NTM MDR-TB test is an innovative technology that offers a cutting-edge approach to the precise diagnosis of tuberculosis and nontuberculous mycobacterial infections (NTM).

Primary outcomes

*Compare between different available tests to reach the most reliable one for better health care service.

Time frame: two years

*Detection of sensitivity and specificity of microscopic examination and Molecular studies using PCR MTB/NTM MDR-TB compared to culture which is the gold standard technique in the diagnosis of TB to reach the most reliable one for better health care service.

Secondary outcomes

*Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.

Time frame: two years

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Abdou Abdelmoula

CONTACT

[email protected]

00201113983636

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospital

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Oct 31, 2024
Registry last updated: Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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