How the immune system responds to mycobacterial infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines immune characteristics across groups including healthy individuals, active pulmonary TB patients, latent TB infection, tuberculous pleurisy, and non-tuberculous mycobacterial infections. Blood samples are taken before treatment and 2–3 months after treatment to explore immune markers. Pleural fluid is collected when available from pleural TB cases to better understand local immune responses. The study aims to identify immune patterns that accompany different mycobacterial infections in a single-center setting.

Why it matters

Who can join: the full rules

Inclusion Criteria and Exclusion Criteria:

Inclusion Criteria：

1. Age ≥ 18 years, all genders and races accepted.
2. Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
3. Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
4. Patients with tuberculous pleurisy with onset within less than 1 week.
5. Voluntarily join this study and sign the informed consent form.
6. Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
7. Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
8. Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
9. Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.

Exclusion Criteria：

1. Immunosuppressive conditions including HIV infection, long-term use (\>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
2. Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
3. Patients with diabetes mellitus.
4. Pregnant or lactating women.
5. Patients unable or unwilling to provide informed consent, or with poor compliance.

Where it's running

• The First Affiliated Hospital of Ningbo University
  Ningbo, China Recruiting

Study contacts

• Study coordinator: Chao Cao
• Email: caodoctor@163.com
• Phone: +86-0574-87089878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.