Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

NCT05097638 | Completed

• 1 other identifier: 5884
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment

Conditions

Pulmonary Tuberculoses; Pulmonary Function; Newborn, Abnormal

Keywords

pulmonary Tuberculosis; Spirometry; Pulmonary Function

Outcome Measures

Primary Outcomes (3)

• Post tuberculosis lung functional impairment

  spirometry abnormality either: restrictive, obstructive, or mixed

  6 months

• post tuberculosis persistent clinical symptoms

  either cough , sputum , breathlessness, hemoptysis

  6 months

• Grading of obstruction function:

  grading according to GOLD : mild , moderate , severe , very severe

  6 months

Study Arms (1)

Cured pulmonary Tuberculosis patients

6 months after a completed course of anti-tuberculosis therapy

Diagnostic Test: spirometry

Interventions

spirometry DIAGNOSTIC_TEST

Patient do spirometry

Cured pulmonary Tuberculosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient more than 18 years old had been newly diagnosed drug-sensitive first episode pulmonary tuberculosis, confirmed by sputum smear microscopy were included in the study. He completed an outpatient course of standard first line anti-tuberculosis therapy (6 months) and declared as cured without radiological change over the past year (in comparable with chest X-ray at the end of TB treatment).

You may qualify if:

• Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured

You may not qualify if:

• Smoker (to avoid spirometry biases).
• Extrapulmonary tuberculosis cases
• Multidrug resistant tuberculosis
• known contraindications to spirometry testing
• Individuals with chest wall deformities or neuromuscular diseases
• Patients who failed to achieve acceptability and reproducibility criteria of the spirometry test
• Defaulter cases or irregular treatment,
• known coexisting chronic lung disease as history of asthma or interstitial lung diseases
• A history of illicit drug use
• Patients with comorbidities: renal and hepatic insufficiency, heart diseases and metabolic disorders.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Chest Department-faculty of medicine-Assuit university

Asyut, Egypt

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Antisocial Personality Disorder

Interventions

Spirometry

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; Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture in Chest and Tuberculosis Department, Faculty of Medicine

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 28, 2021
• Study Start: January 20, 2018
• Primary Completion: November 1, 2019
• Study Completion: February 4, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

EG (1)