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Construction and preliminary validation of a prediction model for anti-tuberculosis drug concentration in spinal tuberculosis lesions based on sclerotic bone classification

Construction and preliminary validation of a prediction model for anti-tuberculosis drug concentration in spinal tuberculosis lesions based on sclerotic bone classification

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128514
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Spinal tuberculosis

Interventions

Non-sclerotic bone group:None
Fragmented sclerotic bone group:None
Non-fragmented sclerotic bone group:None

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with spinal tuberculosis in the outpatient department and scheduled for surgical treatment; 2. This hospitalization is the first time to receive anti-tuberculosis chemotherapy; 3. Aged 18 to 60 years old; 4. American Society of Anesthesiologists (ASA) classification: Grade I-III; 5. Body Mass Index (BMI, Kg/m^2) between 18 and 30; 6. Those who voluntarily join this research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Drug-resistant tuberculosis; 2. Patients with a history of spinal surgery or those with other concurrent spinal diseases; 3. Patients with severe damage to important organs such as the heart, liver, brain, lungs, and kidneys; 4. Pregnant or lactating women, or those with severe mental illnesses; 5. Patients with diabetes whose blood glucose control has not reached the target (fasting blood glucose >11.1 mmol/L, glycated hemoglobin >8.0%) or those with diabetic complications.

Design outcomes

Primary

MeasureTime frame
The concentration of anti-tuberculosis drugs in the lesion;

Secondary

MeasureTime frame
The concentration of anti-tuberculosis drugs in the blood;

Countries

China

Contacts

Public ContactDu Xing

The First Affiliated Hospital of Chongqing Medical University

878959354@qq.com+86 23 89011018

Outcome results

None listed

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