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Effect of Mycobacterial Infection on Immune Status

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Contact Information
Primary
Chao Cao
caodoctor@163.com
+86-0574-87089878
Backup
Shiyi He
shiyihii@163.com
+86-0574-87089878
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2026-07-20
Participants
Target number of participants: 120
Treatments
Immunometabolic differences between DS-TB and MDR-TB
Using a prospective, single-center, observational study design, it is planned to enroll 30 patients divided into drug-susceptible tuberculosis and multidrug-resistant tuberculosis. CyTOF technology was used to analyze the differences in immune subsets and metabolic functions.
To assess the effect of immune status on NTM
A total of 15 patients over the age of 18 diagnosed with non-tuberculous mycobacteria were included, and peripheral blood samples were collected after 2 months of treatment to analyze the changes in immune status and metabolic status of non-tuberculous mycobacterial patients in healthy people.
Significance of studying the immunometabolic status of tuberculous pleurisy
A total of 20 patients over the age of 18 diagnosed with tuberculous pleurisy were included in the plan, divided into high-symptom and low-symptomatic groups, and pleural fluid and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
Study of immunometabolic status in different states of tuberculosis
A total of 15 patients over the age of 18 diagnosed with active pulmonary tuberculosis and 10 patients with latent pulmonary tuberculosis were enrolled, and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
A study of exhaled air condensate in NTM patients versus CAP patients
A total of 30 patients over the age of 18 diagnosed with nontuberculous mycobacteria and 30 healthy or community pneumonia patients were enrolled, and their exhaled air condensate was collected before or within 2 weeks after treatment to analyze its composition.
Sponsors
Leads: First Affiliated Hospital of Ningbo University

This content was sourced from clinicaltrials.gov