Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

NCT02736864 | Completed DMC

• 1 other identifier: FUUMGCD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry

  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).

  At least one year after completion of the tuberculosis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cured pulmonary tuberculosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

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

Uberlândia, Minas Gerais, 38405-320, Brazil

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Thulio Cunha

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduating in Clinical Sciences of Federal University of Uberlândia; Radiologist.

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: April 13, 2016
• Study Start: September 28, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)