TuberculosisNCT06409572
Study of GeneXpert Mycobacterium Tuberculosis/ Rifampicin (MTB/RIF) Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
An observational study of Tuberculosis, run by Sohag University.
Trial summary
1. Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB. 2. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- GeneXpert MTB/RIF
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Sampling:Morning sputum samples or any suspected fluid as pleural or pus. 2. Laboratory investigations: 1. Direct Smear Preparation and Ziehl-Neelsen staining. 2. MTB culture on Lowenstein-Jensen (LJ) media 3. Gene-Xpert MTB/RIF assay.
Who may be able to join
- All suspected tuberculous patients.
Who cannot join
- children
- Previously diagnosed patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of GeneXpert MTB/RIF Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
- Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.
- To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.
Read the detailed description
Tuberculosis (TB) infection, caused by Mycobacterium tuberculosis, is a leading cause of mortality worldwide and ranks among the deadliest infectious diseases, including HIV and malaria. Despite global efforts, TB remains a significant public health threat, particularly in developing and underdeveloped countries. The World Health Organization (WHO) has reported that an estimated 10.4 million people contract new TB infections yearly, with 1.8 million TB-related deaths occurring annually.
TB usually affects the lungs, but it can also affect other parts of the body, such as the brain, spine, and many other organ systems. The most common form is pulmonary TB, which is easily spread by aerosol droplets. If another person inhales air containing these droplet nuclei, the probability of getting infected is very high. The chance of transmissibility increases if there is a delay in disease detection and treatment initiation.
Tuberculosis is an infection that requires extensive treatment. Active pulmonary TB patients can transmit the infection through the air then the droplet nuclei move through upper respiratory tract and bronchi to reach the lungs alveoli.
It is critical to treat active pulmonary TB patients as soon as possible in order to decrease the danger of infection spreading to others. The initial stage in TB diagnosis is sputum acid fast bacillus (AFB) staining, which has an advantage of having an average turnaround time (TAT) about 24 hours.
There are a number of tests available for the diagnosis of tuberculosis each having their own limitations. Conventional microscopy has low sensitivity and culture requires longer time for positivity. The commercially available automated, liquid Mycobacterium Growth Indicator tube (MGIT) culture system is time-consuming and requires specialized laboratories. On the other side, nucleic acid amplification techniques not only provide the advantage of rapidity of diagnosis but also detect even low genomic copies in various specimens and curtail the transmission of the disease.
The World Health Organization (WHO) has endorsed the implementation of GeneXpert MTB/RIF assay for national tuberculosis programs in developing countries. The GeneXpert MTB/RIF is an automated, user friendly and rapid test based on nested real-time polymerase chain reaction (PCR) assay and molecular beacon technology for MTB detection and RIF resistance.
The results are obtained within a short period of time (2 h). Moreover this technique is not prone to cross-contamination, requires minimal Biosafety facilities and has a high sensitivity in smear-negative pulmonary TB. The diagnosis of extrapulmonary tuberculosis (EPTB) is often difficult to establish, considering that number of bacteria in specimens is often very low, a collection often requires invasive procedures, and it is not easy to obtain multiple samples. In this scenario GeneXpert is a potentially useful tool for extrapulmonary specimens.
- Conditions
- Tuberculosis
- Being tested
- GeneXpert MTB/RIF
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneXpert MTB/RIFDiagnostic test
Rapid and accurate method for detection of tuberculosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 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 TuberculosisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hussien Mahran Shehata, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409572
- Sponsor's protocol ID
- Soh-Med-24-4-08MD
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AGRAWAL, M., BAJAJ, A., BHATIA, V. & DUTT, S. 2016. Comparative study of GeneXpert with ZN stain and culture in samples of suspected pulmonary tuberculosis. Journal of clinical and diagnostic research: JCDR, 10, DC09. GONG, X., HE, Y., ZHOU, K., HUA, Y. & LI, Y. 2023. Efficacy of Xpert in tuberculosis diagnosis based on various specimens: a systematic review and meta-analysis. Frontiers in Cellular and Infection Microbiology, 13, 500. GUENAOUI, K., HARIR, N., OUARDI, A., ZEGGAI, S., SELLAM, F., BEKRI, F. & TOUIL, S. C. 2016. Use of GeneXpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases. Annals of translational medicine, 4. KHAN, A. S., ALI, S., KHAN, M. T., AHMED, S., KHATTAK, Y., IRFAN, M. & SAJJAD, W. 2018. Comparison of GeneXpert MTB/RIF assay and LED-FM microscopy for the diagnosis of extra pulmonary tuberculosis in Khyber Pakhtunkhwa, Pakistan. brazilian journal of microbiology, 49, 909-913. KHATER, E. S. & ABDO, K. H. 2022. Role of Gene-Xpert MTB/RIF assay in detection of Mycobacterium tuberculosis in smear-negative sputum samples. Microbes and Infectious Diseases, 3, 606-614. WILLIAM, T., PARAMESWARAN, U., LEE, W. K., YEO, T. W., ANSTEY, N. M. & RALPH, A. P. 2015. Pulmonary tuberculosis in outpatients in Sabah, Malaysia: advanced disease but low incidence of HIV co-infection. BMC infectious diseases, 15, 1-9. ZUMLA, A., GEORGE, A., SHARMA, V., HERBERT, R. H. N., OXLEY, A. & OLIVER, M. 2015. The WHO 2014 global tuberculosis report-further to go. The Lancet Global Health, 3, e10-e12.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of GeneXpert MTB/RIF Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
- ClinicalTrials.gov ID
- NCT06409572
- Acronym / sponsor ID
- Soh-Med-24-4-08MD
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 May 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.
- Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.
- To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.
Detailed description
Tuberculosis (TB) infection, caused by Mycobacterium tuberculosis, is a leading cause of mortality worldwide and ranks among the deadliest infectious diseases, including HIV and malaria. Despite global efforts, TB remains a significant public health threat, particularly in developing and underdeveloped countries. The World Health Organization (WHO) has reported that an estimated 10.4 million people contract new TB infections yearly, with 1.8 million TB-related deaths occurring annually.
TB usually affects the lungs, but it can also affect other parts of the body, such as the brain, spine, and many other organ systems. The most common form is pulmonary TB, which is easily spread by aerosol droplets. If another person inhales air containing these droplet nuclei, the probability of getting infected is very high. The chance of transmissibility increases if there is a delay in disease detection and treatment initiation.
Tuberculosis is an infection that requires extensive treatment. Active pulmonary TB patients can transmit the infection through the air then the droplet nuclei move through upper respiratory tract and bronchi to reach the lungs alveoli.
It is critical to treat active pulmonary TB patients as soon as possible in order to decrease the danger of infection spreading to others. The initial stage in TB diagnosis is sputum acid fast bacillus (AFB) staining, which has an advantage of having an average turnaround time (TAT) about 24 hours.
There are a number of tests available for the diagnosis of tuberculosis each having their own limitations. Conventional microscopy has low sensitivity and culture requires longer time for positivity. The commercially available automated, liquid Mycobacterium Growth Indicator tube (MGIT) culture system is time-consuming and requires specialized laboratories. On the other side, nucleic acid amplification techniques not only provide the advantage of rapidity of diagnosis but also detect even low genomic copies in various specimens and curtail the transmission of the disease.
The World Health Organization (WHO) has endorsed the implementation of GeneXpert MTB/RIF assay for national tuberculosis programs in developing countries. The GeneXpert MTB/RIF is an automated, user friendly and rapid test based on nested real-time polymerase chain reaction (PCR) assay and molecular beacon technology for MTB detection and RIF resistance.
The results are obtained within a short period of time (2 h). Moreover this technique is not prone to cross-contamination, requires minimal Biosafety facilities and has a high sensitivity in smear-negative pulmonary TB. The diagnosis of extrapulmonary tuberculosis (EPTB) is often difficult to establish, considering that number of bacteria in specimens is often very low, a collection often requires invasive procedures, and it is not easy to obtain multiple samples. In this scenario GeneXpert is a potentially useful tool for extrapulmonary specimens.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Sampling:Morning sputum samples or any suspected fluid as pleural or pus. 2. Laboratory investigations: 1. Direct Smear Preparation and Ziehl-Neelsen staining. 2. MTB culture on Lowenstein-Jensen (LJ) media 3. Gene-Xpert MTB/RIF assay.
Key inclusion criteria (1 listed)
- All suspected tuberculous patients.
Key exclusion criteria (2 listed)
- children
- Previously diagnosed patients.
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 |
|---|---|---|
| GeneXpert MTB/RIFRapid and accurate method for detection of tuberculosis. | Diagnostic test | – |
Primary outcome
Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- BackgroundAGRAWAL, M., BAJAJ, A., BHATIA, V. & DUTT, S. 2016. Comparative study of GeneXpert with ZN stain and culture in samples of suspected pulmonary tuberculosis. Journal of clinical and diagnostic research: JCDR, 10, DC09. GONG, X., HE, Y., ZHOU, K., HUA, Y. & LI, Y. 2023. Efficacy of Xpert in tuberculosis diagnosis based on various specimens: a systematic review and meta-analysis. Frontiers in Cellular and Infection Microbiology, 13, 500. GUENAOUI, K., HARIR, N., OUARDI, A., ZEGGAI, S., SELLAM, F., BEKRI, F. & TOUIL, S. C. 2016. Use of GeneXpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases. Annals of translational medicine, 4. KHAN, A. S., ALI, S., KHAN, M. T., AHMED, S., KHATTAK, Y., IRFAN, M. & SAJJAD, W. 2018. Comparison of GeneXpert MTB/RIF assay and LED-FM microscopy for the diagnosis of extra pulmonary tuberculosis in Khyber Pakhtunkhwa, Pakistan. brazilian journal of microbiology, 49, 909-913. KHATER, E. S. & ABDO, K. H. 2022. Role of Gene-Xpert MTB/RIF assay in detection of Mycobacterium tuberculosis in smear-negative sputum samples. Microbes and Infectious Diseases, 3, 606-614. WILLIAM, T., PARAMESWARAN, U., LEE, W. K., YEO, T. W., ANSTEY, N. M. & RALPH, A. P. 2015. Pulmonary tuberculosis in outpatients in Sabah, Malaysia: advanced disease but low incidence of HIV co-infection. BMC infectious diseases, 15, 1-9. ZUMLA, A., GEORGE, A., SHARMA, V., HERBERT, R. H. N., OXLEY, A. & OLIVER, M. 2015. The WHO 2014 global tuberculosis report-further to go. The Lancet Global Health, 3, e10-e12.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Sohag 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Hussien Mahran Shehata, MD (01009003285, e.shehata90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB. (time frame: Baseline). 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 NCT06409572, 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 13 May 2024.