Clinical trial NCT04055441: A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
Official title: A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Tuberculosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - All pulmonary tuberculosis adult patients (age ≥ 18 years) who will attend the outpatient clinic of Chest Department at Assiut University Hospital during 2019 - 2020.

Brief 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.

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: sputum smear conversion
timeFrame: baseline
Secondary outcomes:
measure: sputum culture conversion
timeFrame: baseline
Other outcomes:
measure: time to sputum conversion
timeFrame: baseline
Locations:
Study officials:
affiliation: Assiut University
name: amani omar, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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citation: Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. French.
citation: Assao Neino MM, Gagara Issoufou MA, Ouedraogo 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.
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.