Risk Factors and Biomarkers for Post-tuberculosis Lung Damage

NCT05426720 | Recruiting DMC

• 1 other identifier: M2022296
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.

Conditions

Pulmonary TB

Keywords

post-tuberculosis lung damage; cigarette smoking

Outcome Measures

Primary Outcomes (1)

• lung function

  Forced expiratory volume (FEV1, l/min), and forced vital capacity (FVC,l/min) are the important parameters in lung function. FEV1/FVC, diffusing capacity for carbon monoxide (DLCO), and other indicators, will also be observed during follow-up.

  half a year, 1 year, 2 year, and 3-year follow-up

Secondary Outcomes (1)

• Absorption of TB lesions on lung CT scans after TB treatment

  half a year, 1 year, 2 year, and 3year follow-up

Study Arms (1)

patients with pulmonary tuberculosis

male patients aged 25-60 with active pulmonary tuberculosis

Other: no intervention

Interventions

no intervention OTHER

no intervention; This study is a observational study. All patients received routine anti-tuberculosis regimen. Researchers will observe the clinical manifestation, pulmonary function and pulmonary CT manifestation within a few years after the cure of tuberculosis.

patients with pulmonary tuberculosis

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will enroll male patients who were newly diagnosed with active TB from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital between January 2022 and December 2024.

You may qualify if:

• Male patients aged 25-60 years newly diagnosed with active pulmonary TB.

You may not qualify if:

• patients with positive sputum smear or TB culture results;
• human immunodeficiency virus-positive patients;
• patients infected with multidrug-resistant TB;
• patients with malignant neoplasms (e.g., lung cancer) or severe cardiovascular and cerebrovascular diseases;
• non-compliant patients who were unable to complete the lung function tests;
• patients without lung parenchymal destruction (such as tuberculous pleurisy). -

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Geriatric Hospital: collaborator

Study Sites (2)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Beijing Geriatric Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum cytokines including IL-6, IL-8, MMP and etc will be detected at baseline prior to TB treatment.

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Cigarette Smoking

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; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Yongchang Sun, MD

  Respiratory and Critical Care Department, Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaoyan Gai, MD

CONTACT

13522708870; gxy81wfl79@163.com

Sun

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 22, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CN (2)