Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia

Study Overview
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Brief Summary
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This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects. Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.

Official Title
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Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia

Conditions
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Community Acquired Pneumonia

Intervention / Treatment
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* Drug: Cephalosporins and Macrolide Antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols. Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item: 1. With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain; 2. Fever; 3. With pulmonary consolidation and crackles; 4. White blood cells>10×10^9/L or <4×10^9/L; 5. X-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion. Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity). Exclusion Criteria: It is unable to provide complete medical records or the current condition can not accept the diagnosis process. It does not agree to participate in this study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cephalosporins and Macrolide Antibiotics|The intervention drugs are prescribed by treating caregiver.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration (Cmax) |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to achieve maximum concentration (Tmax) |  | up to 4 weeks | 
| absorption rate constant (ka) |  | up to 4 weeks | 
| elimination rate constant (kel) |  | up to 4 weeks | 
| half-life (t1/2) |  | up to 4 weeks |