Children; Infection Clinical Trial
Official title:
Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies
This study is based on the hypothesis that the pharmacokinetics of anti-infective drugs in children are different from adults. We aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious diseases. In this study, we will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of anti-infective drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in children. It will also set the foundation for further studies to improve anti-infective drug therapies for children.
1.Establish population pharmacokinetic (PPK) models of each anti-infective drug in children
by nonlinear mixed effect modeling (NONMEM).
1. At different timepoint after antibiotic 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 .
2. Plasma samples will be tested by high performance liquid chromatography (HPLC).
3. PPK models of antibiotics will be established by NONMEM program.
4. 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.
1. According the results of PPK models, we will use dosages recommended in models to cure
children infectious diseases in prospective studies. For each antibiotic, 50 children
will be collected.
2. We 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.
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