A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Tuberculosis

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 .

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: marwa hussien kilany, resident; Phone Number: 01064123545; Email: docmero1693@gmail.com
• Study Contact Backup: Name: yousef ahmed yousef, professor; Phone Number: 01025033083; Email: yousefahmad72@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: amani omar, professor, Assiut University

Publications and helpful links

General Publications

• 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.
• Simon K. [Primary pulmonary tuberculosis in adults]. Munch Med Wochenschr. 1970 May 22;112(21):999-1003. No abstract available. German.
• Pirronti T, Cecconi L, Sallustio G, Meduri A, Macis G. Diagnostic imaging of pulmonary tuberculosis. Rays. 1998 Jan-Mar;23(1):93-114. English, Italian.
• Huchon G. [Tuberculous infection and pulmonary tuberculosis in adults]. Rev Mal Respir. 1997 Dec;14 Suppl 5:S49-59. French.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 11, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: pulmonary tuberculosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No