Population Pharmacokinetics of Anti-infective Drugs in Children With Infectious Diseases
7 other identifiers
observational
800
1 country
1
Brief Summary
This study is based on the hypothesis that the pharmacokinetics of anti-infective drugs in children are different from adults. We aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious diseases. In this study, we will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of anti-infective drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in children. It will also set the foundation for further studies to improve anti-infective drug therapies for children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 19, 2017
December 1, 2017
8.3 years
April 10, 2017
December 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
maximum concentration (Cmax)
Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.
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
Study Arms (1)
Children with the usage of anti-infective drugs
Interventions
According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.
Eligibility Criteria
Children with anti-infectious therapies.
You may qualify if:
- Children (0-18 years old) with anti-infective therapy against infectious diseases.
- The anti-infective therapy includes drugs commonly used in children infectious diseases, for example, cephalosporins (such as latamoxef, ceftazidime, ceftriaxone and so on), penicillins (such as penicillin, amoxicillin, ampicillin and so on), macrolides (such as erythromycin, azithromycin and so on), carbapenems (sucn as meropenem, imipenem and so on) and antiviral drugs (such as ganciclovir, acyclovir and so on).
- Children infectious diseases include pneumonia, sepsis, purulent meningitis and other diseases with infection.
- Informed consent signed by the parents and/or guardians.
You may not qualify if:
- Anti-infective drugs aren't involved in the therapies of children.
- It is unable to provide complete medical records or the current condition cannot accept the study process.
- Patients are allergic to anti-infective drugs.
- Parents and/or guardians do not agree to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Children's Hospitallead
- Shandong Universitycollaborator
- Hopital Universitaire Robert-Debrecollaborator
- Rennes University Hospitalcollaborator
Study Sites (1)
Beijing Children's Hospital of Capital Medical University
Beijing, China
Related Publications (9)
Zhao W, Lopez E, Biran V, Durrmeyer X, Fakhoury M, Jacqz-Aigrain E. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013 Jun;98(6):449-53. doi: 10.1136/archdischild-2012-302765. Epub 2012 Dec 19.
PMID: 23254142RESULTLeroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E; French Society of Neonatology. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015 Apr;100(4):394-8. doi: 10.1136/archdischild-2014-306873. Epub 2015 Jan 27.
PMID: 25628457RESULTJacqz-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: 26289222RESULTRamos-Martin V, Johnson A, Livermore J, McEntee L, Goodwin J, Whalley S, Docobo-Perez F, Felton TW, Zhao W, Jacqz-Aigrain E, Sharland M, Turner MA, Hope WW. Pharmacodynamics of vancomycin for CoNS infection: experimental basis for optimal use of vancomycin in neonates. J Antimicrob Chemother. 2016 Apr;71(4):992-1002. doi: 10.1093/jac/dkv451. Epub 2016 Jan 10.
PMID: 26755499RESULTZhao W, Hill H, Le Guellec C, Neal T, Mahoney S, Paulus S, Castellan C, Kassai B, van den Anker JN, Kearns GL, Turner MA, Jacqz-Aigrain E; TINN Consortium. Population pharmacokinetics of ciprofloxacin in neonates and young infants less than three months of age. Antimicrob Agents Chemother. 2014 Nov;58(11):6572-80. doi: 10.1128/AAC.03568-14. Epub 2014 Aug 25.
PMID: 25155587RESULTKan M, Shi HY, Han B, Wu YE, Li Q, Guo ZX, Li X, Hao GX, Zheng Y, Su LQ, Huang X, Sui ZG, Zhao W. Prediction of Unbound Ceftriaxone Concentration in Children: Simple Bioanalysis Method and Basic Mathematical Equation. Antimicrob Agents Chemother. 2020 Dec 16;65(1):e00779-20. doi: 10.1128/AAC.00779-20. Print 2020 Dec 16.
PMID: 33020163DERIVEDShi HY, Wang K, Wang RH, Wu YE, Tang BH, Li X, Du B, Kan M, Zheng Y, Xu BP, Shen AD, Su LQ, Jacqz-Aigrain E, Huang X, Zhao W. Developmental population pharmacokinetics-pharmacodynamics and dosing optimization of cefoperazone in children. J Antimicrob Chemother. 2020 Jul 1;75(7):1917-1924. doi: 10.1093/jac/dkaa071.
PMID: 32129861DERIVEDDong L, Zhai XY, Yang YL, Wang L, Zhou Y, Shi HY, Tang BH, Wu YE, Yang F, Wen L, Kong HX, Zhi LJ, Jacqz-Aigrain E, Zhao W. Population Pharmacokinetics and Dosing Optimization of Imipenem in Children with Hematological Malignancies. Antimicrob Agents Chemother. 2019 May 24;63(6):e00006-19. doi: 10.1128/AAC.00006-19. Print 2019 Jun.
PMID: 30962334DERIVEDDong Q, Leroux S, Shi HY, Xu HY, Kou C, Khan MW, Jacqz-Aigrain E, Zhao W. Pilot Study of Model-Based Dosage Individualization of Ganciclovir in Neonates and Young Infants with Congenital Cytomegalovirus Infection. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e00075-18. doi: 10.1128/AAC.00075-18. Print 2018 May.
PMID: 29507070DERIVED
Biospecimen
whole blood and plasma
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A-Dong Shen, Master
Beijing Children's Hospital of Capital Medical University
- STUDY DIRECTOR
Yu-Jie Qi, Master
Beijing Children's Hospital of Capital Medical University
- STUDY DIRECTOR
Wei Zhao, Doctor
Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief of China National Clinical Research Center for Respiratory Diseases
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 13, 2017
Study Start
June 21, 2017
Primary Completion
October 1, 2025
Study Completion
December 31, 2025
Last Updated
December 19, 2017
Record last verified: 2017-12