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Detecting latent tuberculosis infection and its progress to active tuberculosis via a breath test in high-risk groups: a prospective cohort study

Detecting latent tuberculosis infection and its progress to active tuberculosis via a breath test in high-risk groups: a prospective cohort study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058346
Enrollment
Unknown
Registered
2022-04-07
Start date
2022-06-24
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

tuberculosis

Interventions

Gold Standard:The principle of IGRAs is as follows: After adding tuberculosis antigen ESAT-6 and CFP-10, antigen-presenting cells in whole blood were used to stimulate specific T cells to produce IFN-
Index test:Sensitivity and specificity of exhalation model for diagnosing latent tuberculosis infection.

Sponsors

Shenzhen Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=5 years, no gender limit. 2. There are IGRAs detection results. 3. People who fit one of the following sources: (1) Close contacts of tuberculosis patients. Definition of close contacts of tuberculosis: people who have direct contact with mycopositive tuberculosis patients from 3 months before diagnosis to 2 weeks after the start of anti-tuberculosis, can be divided into close contacts within the family (family members) and close contacts outside the family (colleagues, classmates, etc.). Direct contact is defined as contact time of more than 4 hours in a week, also includes living in the same house, frequent home visits, etc. (2)Staff in specialized tuberculosis hospitals, including doctors, nurses, administrative staff, nurses, etc. (3) The person who comes to the medical examination department for routine medical examination. 4. Local registered population or permanent population, which can ensure the completion of the whole study cycle (Registered population: the population holding local registered population, but the population leaving the local for more than 6 months is not considered as the population to be examined; Foreign resident population: without local household registration, but having resided in the local area continuously for 6 months or more at the time of the survey). 5. Sign the informed consent voluntarily or signed by the guardian, participate in the study and cooperate to complete the study content.

Exclusion criteria

Exclusion criteria: 1. Can not obtain exhaled air sample, or exhaled air bag leakage; 2. Subjects with tuberculosis who have been etiologically confirmed or clinically diagnosed; 3. According to the judgment of the research group, the subjects suffer from any diseases that are not suitable for participating in this subject or may prevent the patients from participating in the whole process of this subject (such as serious mental disorders, alcoholism, drug abuse, Karnofsky score < 50%; Or other related serious illness that may interfere with treatment).

Design outcomes

Primary

MeasureTime frame
The accuracy of TST, IGRA, sputum culture and VOC methods in detecting latent and active tuberculosis infection;

Countries

China

Contacts

Public ContactFu Liang

Shenzhen Third People's Hospital

flk1981@qq.com+86 15989869571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026