NCT07638670 Effect of Mycobacterial Infection on Immune Status
| NCT ID | NCT07638670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Ningbo University |
| Condition | Tuberculosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2026-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-07-09 with a primary completion date of 2026-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07638670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638670 currently recruiting?
Yes, NCT07638670 is actively recruiting participants. Contact the research team at caodoctor@163.com for enrollment information.
Where is the NCT07638670 trial being conducted?
This trial is being conducted at Ningbo, China.
Who is sponsoring the NCT07638670 clinical trial?
NCT07638670 is sponsored by First Affiliated Hospital of Ningbo University. The trial plans to enroll 120 participants.