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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
To establish a multi-immune pathway interaction network and composite biomarkers in mycobacterial infection thing — 3 days before treatment and 2 months after treatment This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Ningbo University
Ningbo
China
Recruiting
More First Affiliated Hospital of Ningbo University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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