Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia
NCT ID: NCT02775968
Last Updated: 2017-06-26
Study Results
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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UNKNOWN
750 participants
OBSERVATIONAL
2017-06-21
2022-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Cephalosporins and Macrolide Antibiotics
The intervention drugs are prescribed by treating caregiver.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 does not agree to participate in this study.
1 Year
18 Years
ALL
No
Sponsors
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Beijing Children's Hospital
OTHER
Responsible Party
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Kunling Shen
Chief of China National Clinical Research Center for Respiratory Diseases
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
Other Identifiers
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BCH_PPK001
Identifier Type: -
Identifier Source: org_study_id
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