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OpenTrials
Completed

NCT Number: NCT02736864

Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

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.

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama)

Uberlândia, Minas Gerais, 38405-320, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2016
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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