Population Pharmacokinetics of Anti-infective Drugs in Children With Infectious Diseases
NCT ID: NCT03113344
Last Updated: 2017-12-19
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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RECRUITING
800 participants
OBSERVATIONAL
2017-06-21
2025-12-31
Brief Summary
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Detailed Description
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1. At different timepoint after antibiotic administration, plasma samples of 100 children will be collected from neonatal intensive care unit (NICU) and pneumology department for each drug. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on .
2. Plasma samples will be tested by high performance liquid chromatography (HPLC).
3. PPK models of antibiotics will be established by NONMEM program.
4. The reliability and stability of the PPK model will be evaluated by 1000 times of Bootstrap procedure and normalized predictive distribution error (NPDE).
2.Evaluation of the clinical feasibility and safety of individualized dosing.
1. According the results of PPK models, we will use dosages recommended in models to cure children infectious diseases in prospective studies. For each antibiotic, 50 children will be collected.
2. We will compare the therapeutic effects and safety between children with conventional therapies and children with individualized therapies, including proportions of children with effective drug concentration, improvement speed of of children, liver and kidney functions of of children, adverse reactions of drugs and so on.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with the usage of anti-infective drugs
cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs
According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.
Interventions
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cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs
According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
1 Day
18 Years
ALL
No
Sponsors
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Shandong University
OTHER
Hopital Universitaire Robert-Debre
OTHER
Rennes University Hospital
OTHER
Beijing Children's Hospital
OTHER
Responsible Party
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Adong Shen
Deputy 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
Yu-Jie Qi, Master
Role: STUDY_DIRECTOR
Beijing Children's Hospital of Capital Medical University
Wei Zhao, Doctor
Role: STUDY_DIRECTOR
Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital
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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Adong Shen, Master
Role: primary
References
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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.
Leroux 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.
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.
Ramos-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.
Zhao 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.
Kan 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.
Shi 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.
Dong 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.
Dong 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.
Other Identifiers
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Yu-Jie Qi
Identifier Type: OTHER
Identifier Source: secondary_id
Wei Zhao
Identifier Type: OTHER
Identifier Source: secondary_id
Hui Qi
Identifier Type: OTHER
Identifier Source: secondary_id
Fei Jin
Identifier Type: OTHER
Identifier Source: secondary_id
Evelyne Jacqz-Aigrain
Identifier Type: OTHER
Identifier Source: secondary_id
Stephanie Leroux
Identifier Type: OTHER
Identifier Source: secondary_id
BCH_PPK002
Identifier Type: -
Identifier Source: org_study_id