Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases
NCT ID: NCT03643497
Last Updated: 2018-08-23
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
800 participants
OBSERVATIONAL
2018-07-01
2021-12-31
Brief Summary
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Detailed Description
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1. At different time point after meropenem or linezolid administration, plasma and/or cerebrospinal fluid samples of 100 children will be collected from pediatric intensive care unit (PICU) for each drug. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on.
2. Plasma and cerebrospinal fluid samples will be tested by high performance liquid chromatography (HPLC).
3. PPK models of meropenem and linezolid 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, the investigators will use dosages recommended in models to cure severe infectious children in prospective studies. For antibiotic drug, 50 children will be collected.
2. The investigators will compare the therapeutic effects and safety between children with conventional therapies and children with individualized therapies in severe infectious diseases, including proportions of children with effective drug concentration, improvement speed of children, liver and kidney functions 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
Children received meropenem or linezolid monotherapy in the treatment of seven infectious diseases
anti-infective 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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anti-infective 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 meropenem and linezolid commonly used in children with infectious diseases,
* Children severe infectious diseases include severe pneumonia, sepsis, purulent meningitis and other diseases with severe 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 meropenem or linezolid.
* 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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Shen A-Dong, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital of Capital Medical University
Qi Yu-Jie, Master
Role: STUDY_DIRECTOR
Beijing Children's Hospital of Capital Medical University
Zhao Wei, 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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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.
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.
Wang Z, Bi J, You D, Tang Y, Liu G, Yu J, Jin Z, Jiang T, Tian X, Qi H, Dong L, Dong L, Zhang Q, Zhao W, Shen A. Improving the efficacy for meropenem therapy requires a high probability of target attainment in critically ill infants and children. Front Pharmacol. 2022 Oct 5;13:961863. doi: 10.3389/fphar.2022.961863. eCollection 2022.
Wang ZM, Chen XY, Bi J, Wang MY, Xu BP, Tang BH, Li C, Zhao W, Shen AD. Reappraisal of the Optimal Dose of Meropenem in Critically Ill Infants and Children: a Developmental Pharmacokinetic-Pharmacodynamic Analysis. Antimicrob Agents Chemother. 2020 Jul 22;64(8):e00760-20. doi: 10.1128/AAC.00760-20. Print 2020 Jul 22.
Other Identifiers
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BCH_PPK004
Identifier Type: -
Identifier Source: org_study_id
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