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Effects of sclerotic bone on the distribution of the first-line anti-tuberculosis drugs concentration between blood and vertebral focus of spinal tuberculosis patients

Effects of sclerotic bone on the distribution of the first-line anti-tuberculosis drugs concentration of spinal tuberculosis patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078914
Enrollment
Unknown
Registered
2023-12-20
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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 group:No
fragmentary sclerotic bone group:No
localized sclerotic margins group:No
multi-focus sclerotic margins group:No
subperiosteal group:No

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: a. Patients diagnosed with spinal tuberculosis in the outpatient department and scheduled for surgical treatment. b. This admission is the first time for anti-tuberculosis chemotherapy. c. Age between 18 to 70 years old d. ASA degree :I-III e. 18 < Body mass index (BMI, Kg/m2) < 30. Volunteer to participate in this study and sign the informed consent

Exclusion criteria

Exclusion criteria: a. Drug-resistant tuberculosis b. Patients with a history of spinal surgery or other spinal diseases. c. Patients with severe functional impairment of heart, liver, brain, lung, kidney and other important organs. d. Pregnant or lactating women, or persons with serious mental illness e. Patients with diabetes whose blood glucose control is not up to standard (fasting blood glucose >11.1mmol/L, glycosylated hemoglobin >8.0%) or with complications of diabetes. a. Patients with uncontrolled hypertension (systolic blood pressure =160mmHg, diastolic blood pressure >90mmHg), or hypotension (resting sitting blood pressure <90/50 MMHG).

Design outcomes

Primary

MeasureTime frame
isoniazid blood concentration;isoniazid health bone tissue concentration;isoniazid focus tissue concentration;rifampin blood concentration;rifampin health bone tissue concentration;rifampin focus tissue concentration;pyrazinamide blood concentration;pyrazinamide health bone tissue concentration;pyrazinamide focus tissue concentration;ethambutol blood concentration;ethambutol health bone tissue concentration;ethambutol focus tissue concentration;

Secondary

MeasureTime frame
C reactive protein;erythrocyte sedimentation rate;

Countries

China

Contacts

Public ContactZhenming Hu

Department of Orthopedics, the First Affiliated Hospital of Chongqing Medical University

spinecenter_hu@126.com+86 136 2832 6226

Outcome results

None listed

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