NCT07638670Recruiting
Effect of Mycobacterial Infection on Immune Status
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 19 May 2026
- Start date
- 9 Jul 2025
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Diseases
- Tuberculosis
- NCT number
- NCT07638670
What you commit to
- Study type: Observational
- Planned participants: 120
- From 9 Jul 2025 to the primary completion date, 20 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
Other illness
- Immunosuppressive conditions including HIV infection, long-term use (\>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
- Patients with diabetes mellitus.
Other
- Pregnant or lactating women.
- Patients unable or unwilling to provide informed consent, or with poor compliance.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.