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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04055441
Collaborator
(none)
60
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
    Anticipated Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Oct 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. sputum smear conversion [baseline]

      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 )

    Secondary Outcome Measures

    1. sputum culture conversion [baseline]

      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 )

    Other Outcome Measures

    1. time to sputum conversion [baseline]

      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 )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 -
    Exclusion Criteria:
    • Patients less than 18 ys. loss of patient follow-up . extrapulmonary tuberculosis.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: amani omar, professor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marwa Hussien kilany, resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04055441
    Other Study ID Numbers:
    • pulmonary tuberculosis
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 13, 2019