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Study of the Molecular Mechanisms Underlying the Cellular Immune Status in Patients with Tuberculosis and Non-Tuberculous Mycobacterial Infections

Study of the Molecular Mechanisms Underlying the Cellular Immune Status in Patients with Tuberculosis and Non-Tuberculous Mycobacterial Infections

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071374
Enrollment
Unknown
Registered
2023-05-12
Start date
2022-07-10
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis and nontuberculous mycobacteria

Interventions

Patients infected with Mycobacterium tuberculosis group:No
Patients infected with non-tuberculous Mycobacteria group:No
Healthy Control group:No

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: MTB patients, NTM patients, and healthy controls. Patients with MTB were expected to include 4-5 cases each of Mycobacterium intracellulace, Mycobacterium Kansas, Mycobacterium avium, Mycobacterium abscess, Mycobacterium Gordon, Mycobacterium toad and Mycobacterium tortoise. Inclusion Criteria: All patients were included as new-onset infection and did not have antituberculous disease prior to enrollment. MTB diagnosis adopts Shengxiang Biotechnology Co., Ltd. Mycobacterium tuberculosis nucleic acid detection kit (PCR-fluorescent probe method) (National Instrument Note 20173400166) combined with microbial culture. NTM was diagnosed by nucleic acid amplification, sequencing and microbial culture. (1) Two sputum samples sent separately for testing had positive NTM culture and were identified as homogeneous bacteria, and/or NTM molecular biology tests were all homogeneous bacteria; (2) Bronchial irrigation fluid or bronchoalveolar lavage fluid NTM culture and/or molecular biology test 1 time positive. Different NTMs were identified by amplification of 16S RNA-coding genes (16S DNA), 16S-23S rRNA intergenic regions (ITS), ß subunits (rpoB) of RNA polymerase and heat shock protein 65 (hsp65) coding genes.

Exclusion criteria

Exclusion criteria: Exclusion criteria for individuals with immunological abnormalities mainly include those with HIV infection, tumors, blood system diseases, rheumatic immune diseases, chronic kidney disease, rheumatic heart disease, Hashimoto's thyroiditis, allergic asthma, and diabetes. In addition, individuals with acute infectious diseases and pregnant women were also excluded.

Design outcomes

Primary

MeasureTime frame
MTB and NTM testing of sputum or bronchial lavage fluid;

Countries

China

Contacts

Public ContactZhancheng Gao

Peking University People's Hospital

gaozhancheng5446@163.com+86 138 1195 7627

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026