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Prevalence and Burden of Bronchiectasis in Tuberculous Patients

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ClinicalTrials.gov Identifier: NCT04085133
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmad Shaddad, Assiut University

Brief Summary:
Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree

Condition or disease Intervention/treatment
Pulmonary Tuberculoses Diagnostic Test: Gene Xpert Chest x ray and MSCT chest

Detailed Description:

Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree.

The prevalence of bronchiectasis is age-related and occurs in every age group and in the pre-antibiotic era . it most often began in childhood. Recent evidence shows that bronchiectasis disproportionately affects women and older individuals and will be contributing to increase in healthcare burden.[3] International data show an increase in the prevalence of bronchiectasis over recent years.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: Prevalence and Burden of Bronchiectasis in Tuberculous Patients
Estimated Study Start Date : September 26, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays


Intervention Details:
  • Diagnostic Test: Gene Xpert Chest x ray and MSCT chest
    Sputum sample for T.B will be done using gene expert device and chest xray and high resolution ct to evaluate bronchectasis


Primary Outcome Measures :
  1. To study prevalence of bronchiectasis in TB patients by case per year. [ Time Frame: One year ]
    How many patients of TB will be diagnosed as abronchiectasis


Secondary Outcome Measures :
  1. To evaluate the burden of bronchiectasis in TB patients [ Time Frame: one year ]
    by frequency of need for hospital admission per year, need for outpatient clinical visits per month and frequency of need for antimicrobial therapy other than anti-tuberculous treatment per month


Biospecimen Retention:   Samples With DNA
Sputum by gene xpert


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Any tuberculosis patients admited to assuit university hospital and assuit chest hospital
Criteria

Inclusion Criteria:

  • 1-patients were diagnosed to have tuberculosis by sputum culture and gene x pert.

    2-patients were diagnosed to have bronchiectasis after lab and radiological examination as well as clinical score.

    3- patients diagnosed as bronchiectasis after history of tuberculosis or anti Tuberculosis treatment with positive or negative tuberculous culture in the time of research.

Exclusion Criteria:

  • 1-patients presented with other Pulmonary diseases. 2-Chronic liver and renal disease . 3- Lung cancer and tumors. 4- patients were previously diagnosed as bronchiectasis .

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Responsible Party: Ahmad Shaddad, DR.Ahmad Shaddad, Assiut University
ClinicalTrials.gov Identifier: NCT04085133    
Other Study ID Numbers: 12345817
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Bronchiectasis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections