TuberculosisNCT06141148
Clinical Presentation, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate
An observational study of Tuberculosis, run by Sohag University at 1 site in Egypt.
Trial summary
Tuberculosis (TB) is an infectious disease that commonly affects the lung and is caused by a bacterium called Mycobacterium Tuberculosis. The bacterium mostly affects people with impaired immunity TB becomes the second leading cause of morbidity and mortality among infectious diseases, following the emergence of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- sputum analysis and lymph node biobsy
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * age above 18ys. * confirmed diagnosis of tuberculosis.
Who may be able to join
- age above 18ys.
- confirmed diagnosis of tuberculosis.
Who cannot join
- childern.
- not confirmed diagnosis of tuberculosis.
Trial locations and contacts
1 site in 1 country.
Hamdy A mohammadin, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy Amin, professor
About this study
Official title: Clinical Presentaion, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate
Tuberculosis (TB) is an infectious disease that commonly affects the lung and is caused by a bacterium called Mycobacterium Tuberculosis. The bacterium mostly affects people with impaired immunity TB becomes the second leading cause of morbidity and mortality among infectious diseases, following the emergence of the human immunodeficiency virus (HIV). HIV is the commonest risk factor for developing a life-threatening tuberculosis disease, on the other hand, HIV related immunodeficiency is worsened by TB infection.TB is among the top 10 causes of death worldwide. In2019, among 8.8 million adults who developed TB disease, 36% were women .TB has become the fifth leading cause of death among women.
- Conditions
- Tuberculosis
- Being tested
- sputum analysis, lymph node biobsy
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sputum analysisDiagnostic test
sputum analysis to diagnose tuberculosis
lymph node biobsyDiagnostic test
Also called to diagnose tuberculous lymphadenitis
to diagnose tuberculous lymphadenitis
| Study group | Role | What they receive |
|---|---|---|
| group A, | group A ( Pulmonary Tuberculosis). Receives: Diagnostic Test: sputum analysis | |
| group B | group B ( Extra pulmnary Tuberculosis). Receives: Diagnostic Test: lymph node biobsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of cured tuberculous patients
to detect percent of cured patients
Measured: 1 year
percent of treatment failure
to detect percent of treatment failure in tuberculous patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohiedin Habeel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141148
- Sponsor's protocol ID
- Soh-Med-23-10-012MS
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali MK, Karanja S, Karama M. Factors associated with tuberculosis treatment outcomes among tuberculosis patients attending tuberculosis treatment centres in 2016-2017 in Mogadishu, Somalia. Pan Afr Med J. 2017 Nov 2;28:197. doi: 10.11604/pamj.2017.28.197.13439. eCollection 2017.
PubMed 29610635Jalal TMT, Abdullah S, Wahab FA, Dir S, Naing NN. Prevalence and Factors Associated with Tuberculosis Treatment Success among TB/HIV Co-Infection in North-East Malaysia. Malays J Med Sci. 2017 Dec;24(6):75-82. doi: 10.21315/mjms2017.24.6.9. Epub 2017 Dec 29.
PubMed 29379389Mason PH, Snow K, Asugeni R, Massey PD, Viney K. Tuberculosis and gender in the Asia-Pacific region. Aust N Z J Public Health. 2017 Jun;41(3):227-229. doi: 10.1111/1753-6405.12619. Epub 2016 Dec 13. No abstract available.
PubMed 27960224Horton KC, MacPherson P, Houben RM, White RG, Corbett EL. Sex Differences in Tuberculosis Burden and Notifications in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. PLoS Med. 2016 Sep 6;13(9):e1002119. doi: 10.1371/journal.pmed.1002119. eCollection 2016 Sep.
PubMed 27598345
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentaion, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate
- ClinicalTrials.gov ID
- NCT06141148
- Acronym / sponsor ID
- Soh-Med-23-10-012MS
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Nov 2023 (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.
Tuberculosis (TB) is an infectious disease that commonly affects the lung and is caused by a bacterium called Mycobacterium Tuberculosis. The bacterium mostly affects people with impaired immunity TB becomes the second leading cause of morbidity and mortality among infectious diseases, following the emergence of the human immunodeficiency virus (HIV). HIV is the commonest risk factor for developing a life-threatening tuberculosis disease, on the other hand, HIV related immunodeficiency is worsened by TB infection.TB is among the top 10 causes of death worldwide. In2019, among 8.8 million adults who developed TB disease, 36% were women .TB has become the fifth leading cause of death among women.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A, | – | Diagnostic Test: sputum analysisgroup A ( Pulmonary Tuberculosis). |
| group B | – | Diagnostic Test: lymph node biobsygroup B ( Extra pulmnary Tuberculosis). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * age above 18ys. * confirmed diagnosis of tuberculosis.
Key inclusion criteria (2 listed)
- age above 18ys.
- confirmed diagnosis of tuberculosis.
Key exclusion criteria (2 listed)
- childern.
- not confirmed diagnosis of tuberculosis.
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 |
|---|---|---|
| sputum analysissputum analysis to diagnose tuberculosis | Diagnostic test | group A, |
| lymph node biobsyAlso: to diagnose tuberculous lymphadenitisto diagnose tuberculous lymphadenitis | Diagnostic test | group B |
Primary outcome
percent of cured tuberculous patients
Time frame: 1 year
to detect percent of cured patients
percent of treatment failure
Time frame: 1 year
to detect percent of treatment failure in tuberculous patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 29610635Ali MK, Karanja S, Karama M. Factors associated with tuberculosis treatment outcomes among tuberculosis patients attending tuberculosis treatment centres in 2016-2017 in Mogadishu, Somalia. Pan Afr Med J. 2017 Nov 2;28:197. doi: 10.11604/pamj.2017.28.197.13439. eCollection 2017.
- Background: PubMed 29379389Jalal TMT, Abdullah S, Wahab FA, Dir S, Naing NN. Prevalence and Factors Associated with Tuberculosis Treatment Success among TB/HIV Co-Infection in North-East Malaysia. Malays J Med Sci. 2017 Dec;24(6):75-82. doi: 10.21315/mjms2017.24.6.9. Epub 2017 Dec 29.
- Background: PubMed 27960224Mason PH, Snow K, Asugeni R, Massey PD, Viney K. Tuberculosis and gender in the Asia-Pacific region. Aust N Z J Public Health. 2017 Jun;41(3):227-229. doi: 10.1111/1753-6405.12619. Epub 2016 Dec 13. No abstract available.
- Background: PubMed 27598345Horton KC, MacPherson P, Houben RM, White RG, Corbett EL. Sex Differences in Tuberculosis Burden and Notifications in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. PLoS Med. 2016 Sep 6;13(9):e1002119. doi: 10.1371/journal.pmed.1002119. eCollection 2016 Sep.
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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.
Hamdy A mohammadin, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Sohag University at 1 site in Egypt.
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 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 mohamed mohey, resident (01110721019, mohamedmohie@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of cured tuberculous patients (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06141148, which also lists 4 linked publications.
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 21 Nov 2023.