NCT06141148

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

  • percent of cured tuberculous patients

    to detect percent of cured patients

    1 year

  • percent of treatment failure

    to detect percent of treatment failure in tuberculous patients

    1 year

Study Arms (2)

group A,

group A ( Pulmonary Tuberculosis).

Diagnostic Test: sputum analysis

group B

group B ( Extra pulmnary Tuberculosis).

Diagnostic Test: lymph node biobsy

Interventions

sputum analysisDIAGNOSTIC_TEST

sputum analysis to diagnose tuberculosis

group A,
lymph node biobsyDIAGNOSTIC_TEST

to diagnose tuberculous lymphadenitis

Also known as: to diagnose tuberculous lymphadenitis
group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* age above 18ys. * confirmed diagnosis of tuberculosis.

You may qualify if:

  • age above 18ys.
  • confirmed diagnosis of tuberculosis.

You may not qualify if:

  • childern.
  • not confirmed diagnosis of tuberculosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29610635BACKGROUND

  • Jalal 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.

    PMID: 29379389BACKGROUND

  • Mason 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.

    PMID: 27960224BACKGROUND

  • Horton 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.

    PMID: 27598345BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

mohamed mohey, resident

CONTACT

01110721019mohamedmohie@med.sohag.edu.eg

Hamdy A mohammadin, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-chest department-sohag hospital university

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

November 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

EG(1)