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Trial record 70 of 3326 for:    China Medicine University Hospital

Population Pharmacokinetics of Anti-infective Drugs in Children With Infectious Diseases

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ClinicalTrials.gov Identifier: NCT03113344
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Shandong University
Robert Debré Hospital
Rennes University Hospital
Information provided by (Responsible Party):
Adong Shen, Beijing Children's Hospital

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.

Condition or disease Intervention/treatment
Children; Infection Drug: cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs

Detailed Description:

1.Establish population pharmacokinetic (PPK) models of each anti-infective drug in children by nonlinear mixed effect modeling (NONMEM).

  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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Years
Official Title: Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Penicillins

Group/Cohort Intervention/treatment
Children with the usage of anti-infective drugs Drug: 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 Names:
  • latamoxef
  • ceftriaxone
  • ceftazidime
  • ampicillin
  • penicillin
  • amoxicillin
  • erythromycin
  • azithromycin
  • meropenem
  • imipenem
  • ganciclovir
  • acyclovir




Primary Outcome Measures :
  1. maximum concentration (Cmax) [ Time Frame: up to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. time to achieve maximum concentration (Tmax) [ Time Frame: up to 4 weeks ]
    Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed.

  2. absorption rate constant (ka) [ Time Frame: up to 4 weeks ]
    Ka is the rate constant of drug absorption.

  3. elimination rate constant (kel) [ Time Frame: up to 4 weeks ]
    The elimination rate constant is a value used in pharmacokinetics to describe the rate at which a drug is removed from the system.

  4. half-life (t1/2) [ Time Frame: up to 4 weeks ]
    Half-life is the time required for a quantity to reduce to half its initial value.


Biospecimen Retention:   Samples With DNA
whole blood and plasma


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with anti-infectious therapies.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113344


Contacts
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Contact: A-Dong Shen, Master +86-010-59616898 shenad16@hotmail.com

Locations
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China
Beijing Children's Hospital of Capital Medical University Recruiting
Beijing, China
Contact: Adong Shen, Master    13370115087    shenad16@hotmail.com   
Sponsors and Collaborators
Beijing Children's Hospital
Shandong University
Robert Debré Hospital
Rennes University Hospital
Investigators
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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

Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adong Shen, Deputy Chief of China National Clinical Research Center for Respiratory Diseases, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT03113344     History of Changes
Other Study ID Numbers: BCH_PPK002
Yu-Jie Qi ( Other Identifier: Beijing Children's Hospital )
Wei Zhao ( Other Identifier: Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital )
Hui Qi ( Other Identifier: Beijing Children's Hospital )
Fei Jin ( Other Identifier: Beijing Children's Hospital )
Evelyne Jacqz-Aigrain ( Other Identifier: Robert Debre Hospital,Paris France )
Stephanie Leroux ( Other Identifier: Centre Hospitalier Universitaire de Rennes, France )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antiviral Agents
Penicillins
Erythromycin
Cephalosporins
Anti-Infective Agents
Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action