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

December 17, 2017 updated by: Adong Shen, Beijing Children's Hospital

Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Children's Hospital of Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with anti-infectious therapies.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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:
  • ampicillin
  • amoxicillin
  • ceftazidime
  • meropenem
  • ceftriaxone
  • azithromycin
  • latamoxef
  • penicillin
  • erythromycin
  • imipenem
  • ganciclovir
  • acyclovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absorption rate constant (ka)
Time Frame: up to 4 weeks
Ka is the rate constant of drug absorption.
up to 4 weeks
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.
up to 4 weeks
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.
up to 4 weeks
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.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Collaborators

Hopital Universitaire Robert-Debre
Shandong University
Rennes University Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2017

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 17, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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