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Pharmacokinetic-Pharmacodynamic Modeling of Isoniazid in Patients with Bone Tuberculosis

Pharmacokinetic-Pharmacodynamic Modeling of Isoniazid in Patients with Bone Tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112531
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-20
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Bone tuberculosis

Interventions

Joint tuberculosis Group:None

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with bone or joint tuberculosis (spine, hip, knee, etc.) by pathology or microbiology; 2. No age or gender restrictions; 3. Receiving regular anti-tuberculosis drug treatment, with a regimen that includes isoniazid (patients must have taken oral medication for at least 4 weeks before surgery, and isoniazid will be administered intravenously after admission); 4. Planned to undergo surgical treatment with clear surgical indications; 5. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Those with a severe allergy to isoniazid; 3. Individuals with severe mental illness or those unable to comply with follow-up.

Design outcomes

Primary

MeasureTime frame
Drug concentration;

Secondary

MeasureTime frame
Cmax;Tmax;Bone/Blood AUC ratio;Peak Penetration Factor, PF;

Countries

China

Contacts

Public ContactChengxiang Li

Shanghai Public Health Clinical Center

lichengxiang@shaphc.org+86 189 1872 9839

Outcome results

None listed

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