Effect of Mycobacterial Infection on Immune Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
Study Overview
Brief Summary
This study, titled "Effect of Mycobacterial Infection on Immune Status" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals/community-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Inclusion Criteria：
- •Age ≥ 18 years, all genders and races accepted.
- •Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
- •Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
- •Patients with tuberculous pleurisy with onset within less than 1 week.
- •Voluntarily join this study and sign the informed consent form.
- •Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
- •Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
- •Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
- •Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.
- •Exclusion Criteria：
- •Immunosuppressive conditions including HIV infection, long-term use (>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
- •Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
- •Patients with diabetes mellitus.
- •Pregnant or lactating women.
- •Patients unable or unwilling to provide informed consent, or with poor compliance.
Investigators
Chao Cao, Ph.D.
Principal Investigator
First Affiliated Hospital of Ningbo University