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National Science and Technology Major Project: "Innovation of Short-course Treatment Regimens for Asymptomatic Tuberculosis Based on Intelligent Decision-making and Patient-centered Comprehensive Outcomes Optimization" – Sub-project 5: "Establishment of an AI-driven Short-course Regimen Optimization and Multi-dimensional Outcome Evaluation System"

National Science and Technology Major Project: "Innovation of Short-course Treatment Regimens for Asymptomatic Tuberculosis Based on Intelligent Decision-making and Patient-centered Comprehensive Outcomes Optimization" – Sub-project 5: "Establishment of an AI-driven Short-course Regimen Optimization and Multi-dimensional Outcome Evaluation System"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126945
Enrollment
Unknown
Registered
2026-06-20
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

pulmonary tuberculosis

Interventions

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Real World Cohort: (1) Aged >=12 years, both sexes. (2) Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who received TB treatment; (3) Any diagnostic field contains "keywords related to tuberculosis diagnosis (pulmonary tuberculosis, tracheal tuberculosis, pleural tuberculosis, tuberculous pleurisy, hematogenous disseminated tuberculosis, miliary tuberculosis)", or the diagnostic code contains "ICD codes related to pulmonary tuberculosis and their diagnostic names (1B10.0 Respiratory tuberculosis, confirmed; 1B10.1 Respiratory tuberculosis, unconfirmed; 1B10.Z Respiratory tuberculosis, not specified as bacteriologically or histologically confirmed; 1B13.0&XA57M6 Acute miliary tuberculosis of a single specified site, lung; 1B13.1&XA57M6 Acute miliary tuberculosis of multiple sites, lung; 1B13.2 Acute miliary tuberculosis, unspecified site; 1B13.Z Miliary tuberculosis, unspecified)" for the patient. (4) Initiation of TB treatment on or after January 1, 2021; (5) Complete key diagnosis and treatment data available in the electronic medical record system. 2.Prospective Cohort: (1) Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who is planning to start TB treatment; (2) Voluntary participation with signed informed consent form (for adults >=18 years); parental / guardian consent and co-signed informed consent form are required for minors aged <= 18 years.

Exclusion criteria

Exclusion criteria: 1. Co-morbidity confounding: the presence of other active, life-threatening disease (e.g. late-stage malignancy, non-HIV severe immunodeficiency) for which the expected survival or priority of treatment may substantially interfere with the attribution of TB treatment outcomes; 2. Extremely poor treatment adherence: documented evidence indicating that the patient either never initiated treatment or was permanently lost to follow-up within the early treatment period (<2 weeks), precluding the collection of any valid outcome data.

Design outcomes

Primary

MeasureTime frame
Predictive Performance of the model, the Area Under the Receiver Operating Characteristic curve (AUROC) ;

Secondary

MeasureTime frame
Calibration and Reliability of the Model;Sensitivity, specificity, positive predictive value, and negative predictive value;

Countries

China

Contacts

Public ContactWenhong Zhang

Huashan Hospital, Fudan University

zhangwenhong@fudan.edu.cn+86 21 52888123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026