Clinical trial NCT02775968: Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia
Official title: Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community Acquired Pneumonia
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 750
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (1-18 years of age) receiving drugs per standard of care as prescribed by treating caregiver.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: maximum concentration (Cmax)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: time to achieve maximum concentration (Tmax)
timeFrame: up to 4 weeks
measure: absorption rate constant (ka)
timeFrame: up to 4 weeks
measure: elimination rate constant (kel)
timeFrame: up to 4 weeks
measure: half-life (t1/2)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital of Capital Medical University
Study officials:
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: A-Dong Shen, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Children's Hospital of Capital Medical University, China; China National Clinical Research Center for Respiratory Diseases
name: Bao-Ping Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4.
citation: Ho PL, Lo PY, Chow KH, Lau EH, Lai EL, Cheng VC, Kao RY. Vancomycin MIC creep in MRSA isolates from 1997 to 2008 in a healthcare region in Hong Kong. J Infect. 2010 Feb;60(2):140-5. doi: 10.1016/j.jinf.2009.11.011. Epub 2009 Dec 2.
citation: Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.