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

Community Acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02775968
• Other study ID #: BCH_PPK001
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2016
• Last updated: June 23, 2017
• Start date: June 21, 2017
• Est. completion date: October 2022

Study information

• Verified date: June 2017
• Source: Beijing Children's Hospital
• Contact: A-Dong Shen, Master
• Phone: 8601059616898
• Email: shenad16[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Cephalosporins and Macrolide Antibiotics
The intervention drugs are prescribed by treating caregiver.

Locations

Country	Name	City	State
China	Beijing Children's Hospital of Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum concentration (Cmax)		up to 4 weeks
Secondary	time to achieve maximum concentration (Tmax)		up to 4 weeks
Secondary	absorption rate constant (ka)		up to 4 weeks
Secondary	elimination rate constant (kel)		up to 4 weeks
Secondary	half-life (t1/2)		up to 4 weeks