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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02775968
Enrollment
750
Registered
2016-05-18
Start date
2017-06-21
Completion date
2022-10-31
Last updated
2017-06-26

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

Conditions

Community Acquired Pneumonia

Brief summary

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.

Interventions

DRUGCephalosporins and Macrolide Antibiotics

The intervention drugs are prescribed by treating caregiver.

Sponsors

Beijing Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
maximum concentration (Cmax)up to 4 weeks

Secondary

MeasureTime 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

Countries

China

Contacts

Primary ContactA-Dong Shen, Master
shenad16@hotmail.com8601059616898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026