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Construction and validation of a population pharmacokinetic model for the HRZE regimen for children with tuberculosis

Construction and validation of a population pharmacokinetic model for the HRZE regimen for children with tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099496
Enrollment
Unknown
Registered
2025-03-25
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Tuberculosis in children

Interventions

Observation group:None

Sponsors

Pharmacy Department, Pediatric Infectious Diseases Department
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: It conforms to the diagnostic standards of WHO and China's guidelines for diagnosis and treatment of tuberculosis in children; Sensitive to isoniazid, rifampicin, pyrazinamide, and ethambutol; Oral administration; Under 18 years old; No other serious underlying diseases; No pregnancy

Exclusion criteria

Exclusion criteria: Known allergies to isoniazid, rifampicin, pyrazinamide, ethambutol or their excipients; Liver dysfunction or liver disease (referring to before medication); Patients with severe gastrointestinal reactions; Patients with poor medication adherence (Morosky scale evaluation<6 points).

Design outcomes

Primary

MeasureTime frame
Drug concentration;Clinical efficacy;—

Secondary

MeasureTime frame
Routine blood test results;Liver function;Renal function;Alkaline phosphatase;—

Countries

China

Contacts

Public ContactLiang Huang

West China Second Hospital of Sichuan University

hliang@scu.edu.cn+86 180 3041 1562

Outcome results

None listed

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