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

NCT02775968 | Unknown

• 1 other identifier: BCH_PPK001
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• maximum concentration (Cmax)

  up to 4 weeks

Secondary Outcomes (4)

• 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

Interventions

Cephalosporins and Macrolide Antibiotics DRUG

The intervention drugs are prescribed by treating caregiver.

Also known as: azithromycin, erythromycin, cefamandole, latamoxef, ceftriaxone

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children (1-18 years of age) receiving drugs per standard of care as prescribed by treating caregiver.

You may qualify if:

• 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:
• \. With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain;
• \. Fever;
• \. With pulmonary consolidation and crackles;
• \. White blood cells\>10×10\^9/L or \<4×10\^9/L;
• \. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Beijing Children's Hospital of Capital Medical University

Beijing, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 26289222 BACKGROUND

• 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.

  PMID: 19961873 BACKGROUND

• 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.

  PMID: 13679531 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Cephalosporins; Macrolides; Azithromycin; Erythromycin; Cefamandole; Moxalactam; Ceftriaxone

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactones; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Sulfides; Cefotaxime; Cephacetrile

Study Officials

• A-Dong Shen, Master

  Beijing Children's Hospital of Capital Medical University, China

  PRINCIPAL INVESTIGATOR

• Bao-Ping Xu, MD

  Beijing Children's Hospital of Capital Medical University, China; China National Clinical Research Center for Respiratory Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A-Dong Shen, Master

CONTACT

8601059616898; shenad16@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of China National Clinical Research Center for Respiratory Diseases

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 18, 2016
• Study Start: June 21, 2017
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)