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

NCT ID: NCT02775968

Last Updated: 2017-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-21

Study Completion Date

2022-10-31

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.

Detailed Description

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Conditions

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Community Acquired Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cephalosporins and Macrolide Antibiotics

The intervention drugs are prescribed by treating caregiver.

Intervention Type DRUG

Other Intervention Names

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azithromycin erythromycin cefamandole latamoxef ceftriaxone

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kunling Shen

Chief of China National Clinical Research Center for Respiratory Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A-Dong Shen, Master

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital of Capital Medical University, China

Bao-Ping Xu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Beijing Children's Hospital of Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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A-Dong Shen, Master

Role: CONTACT

8601059616898

Facility Contacts

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Adong Shen, Master

Role: primary

13370115087

References

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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.

Reference Type BACKGROUND
PMID: 26289222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19961873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13679531 (View on PubMed)

Other Identifiers

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BCH_PPK001

Identifier Type: -

Identifier Source: org_study_id

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