Tuberculosis DiagnosisNCT06666972
Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospitals
An observational study of Tuberculosis Diagnosis, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis Diagnosis
- What is being tested?
- PCR MTB/NTM
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with signs and symptoms of tuberculosis (suspected cases) and Patients diagnosed with tuberculosis of both sexes admitted to Assiut university hospitals
Who may be able to join
- Patients with signs and symptoms of tuberculosis (suspected cases)
- Patients diagnosed with tuberculosis.
Who cannot join
- Patients with pulmonary infections other than TB
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospital
- 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.
Read the detailed description
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.
- Conditions
- Tuberculosis Diagnosis
- Being tested
- PCR MTB/NTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR MTB/NTMDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
*Compare between different available tests to reach the most reliable one for better health care service.
*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.
Measured: two years
Secondary outcomes (1)
*Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis DiagnosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdou Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666972
- Sponsor's protocol ID
- TB diagnosis in AssiutU
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rakotosamimanana N, Rabodoarivelo MS, Palomino JC, Martin A, Razanamparany VR. Exploring tuberculosis by molecular tests on DNA isolated from smear microscopy slides. Int J Infect Dis. 2017 Mar;56:248-252. doi: 10.1016/j.ijid.2016.12.005. Epub 2016 Dec 12.
PubMed 27979786
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06666972
- Acronym / sponsor ID
- TB diagnosis in AssiutU
- Conditions
- Tuberculosis Diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with signs and symptoms of tuberculosis (suspected cases) and Patients diagnosed with tuberculosis of both sexes admitted to Assiut university hospitals
Key inclusion criteria (2 listed)
- Patients with signs and symptoms of tuberculosis (suspected cases)
- Patients diagnosed with tuberculosis.
Key exclusion criteria (1 listed)
- Patients with pulmonary infections other than TB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR MTB/NTM• 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). | Diagnostic test | – |
Primary outcome
*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.
1 secondary outcome
*Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 27979786Rakotosamimanana N, Rabodoarivelo MS, Palomino JC, Martin A, Razanamparany VR. Exploring tuberculosis by molecular tests on DNA isolated from smear microscopy slides. Int J Infect Dis. 2017 Mar;56:248-252. doi: 10.1016/j.ijid.2016.12.005. Epub 2016 Dec 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Diagnosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Abdou Abdelmoula (00201113983636, abdou.mahmoud93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
*Compare between different available tests to reach the most reliable one for better health care service. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06666972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.