Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
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|ClinicalTrials.gov Identifier: NCT03625739|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment|
|Tuberculosis||Drug: anti-tuberculosis drug|
1.Establish population pharmacokinetic (PPK) models of each anti-tuberculsis drug in children by nonlinear mixed effect modeling (NONMEM).
- At different timepoint after anti-tuberculsis drug administration, plasma samples of 100 children will be collected from neonatal intensive care unit (NICU) and pneumology department for each drug. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on .
- Plasma samples will be tested by high performance liquid chromatography (HPLC).
- PPK models of anti-tuberculsis drug will be established by NONMEM program.
- The reliability and stability of the PPK model will be evaluated by 1000 times of Bootstrap procedure and normalized predictive distribution error (NPDE).
2.Evaluation of the clinical feasibility and safety of individualized dosing.
- According the results of PPK models, the investigators will use dosages recommended in models to cure TB children in prospective studies. For anti-tuberculsis drug, 50 children will be collected.
- The investigators will compare the therapeutic effects and safety between children with conventional therapies and children with individualized therapies, including proportions of children with effective drug concentration, improvement speed of of children, liver and kidney functions of of children, adverse reactions of drugs and so on.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||18 Years|
|Official Title:||Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||October 1, 2026|
|Estimated Study Completion Date :||December 31, 2026|
- Drug: anti-tuberculosis drug
The intervention drugs are prescribed by treating caregiverOther Names:
- Kanamycin (Streptomycin)
- p-aminosalicylic acid
- maximum concentration (Cmax) [ Time Frame: up to 4 weeks ]Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum
- time to achieve maximum concentration (Tmax) [ Time Frame: up to 4 weeks ]Tmax is the term used in pharmacokinetics to describe the time at which the Cmax
- absorption rate constant (ka) [ Time Frame: up to 4 weeks ]Ka is the rate constant of drug absorption.
- elimination rate constant (kel) [ Time Frame: up to 4 weeks ]The elimination rate constant is a value used in pharmacokinetics to describe the rate at which a drug is removed from the system.
- half-life (t1/2) [ Time Frame: up to 4 weeks ]Half-life is the time required for a quantity to reduce to half its initial value.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625739
|Contact: A-Dong Shen, Masterfirstname.lastname@example.org|
|Beijing Children's Hospital of Capital Medical University||Recruiting|
|Contact: Adong Shen, Master 13370115087 email@example.com|
|Principal Investigator:||A-Dong Shen, Master||Beijing Children's Hospital of Capital Medical University|
|Study Director:||Yu-Jie Qi, Master||Beijing Children's Hospital of Capital Medical University|
|Study Director:||Wei Zhao, Doctor||Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital|