Effect of Mycobacterial Infection on Immune Status
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tuberculosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- To establish a multi-immune pathway interaction network and composite biomarkers in mycobacterial infection thing [Time frame: 3 days before treatment and 2 months after treatment]
Secondary outcome measures (8)
- Immune cell subsets and mechanisms of possible effects of anti-tuberculosis drugs [Time frame: 3 days before treatment and 2 months after treatment]
- Differences in immune subsets between normal persons and patients with active pulmonary tuberculosis [Time frame: 3 days before treatment and 2 months after treatment]
- To explore whether the peripheral blood before treatment contains a certain marker can predict the short-term efficacy [Time frame: 3 days before treatment and 2 months after treatment]
- Comparison of the dynamic changes of immune subsets in peripheral blood and pleural effusion of TP patients before and after treatment [Time frame: 3 days before treatment and 2 months after treatment]
- To explore the differences of peripheral blood immune subsets between TP patients and healthy people before treatment [Time frame: 3 days before treatment and 2 months after treatment]
- To explore the metabolic differences of three major nutrients between TP patients and healthy people before treatment [Time frame: 3 days before treatment and 2 months after treatment]
- Differences in metabolic function between multidrug-resistant tuberculosis group and drug-sensitive tuberculosis group [Time frame: 3 days before treatment and 2 months after treatment]
- Influence of immune status on the efficacy of NTM [Time frame: 3 days before treatment and 2 months after treatment]
Eligibility criteria
Inclusion Criteria and 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Ningbo University — Ningbo
Identifiers
NCT: NCT07638670 · 2025-157A-01