Effect of Mycobacterial Infection on Immune Status

NCT07638670 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Ningbo University

Phase

Observational

Started

2025-07-09

Last updated

2026-06-10

Condition(s) studied

Tuberculosis

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Value of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis. Recruiting

Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma Enrolling by invitation

Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy Recruiting

Intestinal Microbiota Transplantation, Radiochemotherapy and Sintilimab in Localized Advanced Colon Cancer Enrolling by invitation

Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility Starting soon

Other trials for the same condition

Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis Recruiting

Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above Recruiting

BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children Recruiting

Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis Enrolling by invitation

Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial Starting soon

Official registry record

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.

View NCT07638670 on ClinicalTrials.gov ↗ ← All trials in China