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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04055441
Other study ID # pulmonary tuberculosis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2019
Est. completion date October 2020

Study information

Verified date August 2019
Source Assiut University
Contact marwa hussien kilany, resident
Phone 01064123545
Email docmero1693@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of the investigator's study is to detect the characteristics, pattern and outcome of pulmonary tuberculosis patients treated at Assiut University Hospital by collecting their demographic, clinical, laboratory and radiological data.


Description:

Tuberculosis (TB) is a problem of global importance, it is a medical, social and economic disaster of immense magnitude that is occurring over the world

TB remains one of the major health risks associated with morbidity and mortality. Worldwide, about 10 million TB cases have been reported in 2017, and about 1.57 million cases have died The estimated global average risk of infection is 1%, implying approximately 38 million new infections per year among the previously uninfected population .

In Egypt ,researchers have found evidences of tuberculosis in the Egyptian mummies dating from 3000 to 2400 Before Christ and WHO reported that TB is the most important public health problem after hepatitis C , TB disease can affect any organ, but most commonly occurs in the lungs (70%-80%). Pulmonary TB is the most important form of TB infection, because an infection of the lungs is highly contagious due to the mode of droplet transmission .

Patients with TB usually manifest diverse signs and symptoms that vary with age, sex and the associated socio-environmental as well as host factors .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All pulmonary tuberculosis adult patients (age = 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.

Exclusion Criteria:

- Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

Assao Neino MM, Gagara Issoufou MA, Ouédraogo AR, Marcellin KA, Maizoumbou DA, Mamadou S. [The current situation with sputum positive pulmonary tuberculosis in Niamey (Niger)]. Rev Mal Respir. 2019 May;36(5):578-582. doi: 10.1016/j.rmr.2018.07.009. Epub 2019 Apr 19. French. — View Citation

Cai EZ, Chua SM, Tan M, Tambyah PA. Tuberculosis care: enhancing directly observed therapy in a peri-urban, low socioeconomic status neighbourhood. Singapore Med J. 2019 Jul;60(7):334-336. doi: 10.11622/smedj.2019072. — View Citation

Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. Review. French. — View Citation

Pirronti T, Cecconi L, Sallustio G, Meduri A, Macis G. Diagnostic imaging of pulmonary tuberculosis. Rays. 1998 Jan-Mar;23(1):93-114. Review. English, Italian. — View Citation

Rozenshtein A, Hao F, Starc MT, Pearson GD. Radiographic appearance of pulmonary tuberculosis: dogma disproved. AJR Am J Roentgenol. 2015 May;204(5):974-8. doi: 10.2214/AJR.14.13483. Review. — View Citation

Simon K. [Primary pulmonary tuberculosis in adults]. Munch Med Wochenschr. 1970 May 22;112(21):999-1003. German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other time to sputum conversion type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture ) baseline
Primary sputum smear conversion type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture ) baseline
Secondary sputum culture conversion type of positive sample (spontaneous sputum , induced sputum , bronchoalveolar lavage) , technique used for AFB detection (Ziehl - Neelsen (ZN) staining , GeneXpert , conventional TB culture , non-conventional culture ) baseline
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