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Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

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ClinicalTrials.gov Identifier: NCT02736864
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Godoy Canazza Damian, Federal University of Uberlandia

Brief Summary:
The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

Condition or disease
Pulmonary Tuberculosis

Detailed Description:
This study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis




Primary Outcome Measures :
  1. Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry [ Time Frame: At least one year after completion of the tuberculosis treatment ]

    High resolution computed tomography of the lungs will be evaluated by radiologists and the extent of pulmonary abnormalities will be score subjectively.

    Spirometry will permit assessment of lung volumes: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cured pulmonary tuberculosis
Criteria

Inclusion Criteria:

  • Pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment);
  • Treatment finalized at least one year before.

Exclusion Criteria:

  • Physically impaired to perform the functional tests;
  • Coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis);
  • Pregnants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736864


Locations
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Brazil
Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama)
Uberlândia, Minas Gerais, Brazil, 38405-320
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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Principal Investigator: Thulio Cunha Federal University of Uberlandia

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Responsible Party: Michelle Godoy Canazza Damian, Post-graduating in Clinical Sciences of Federal University of Uberlândia; Radiologist., Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02736864     History of Changes
Other Study ID Numbers: FUUMGCD
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections