Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia

June 23, 2017 updated by: Kunling Shen, Beijing Children's Hospital

Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia

This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects.

Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

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

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children (1-18 years of age) receiving drugs per standard of care as prescribed by treating caregiver.

Description

Inclusion Criteria:

  • Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols.

  • Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item:

    • 1. With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain;
    • 2. Fever;
    • 3. With pulmonary consolidation and crackles;
    • 4. White blood cells>10×10^9/L or <4×10^9/L;
    • 5. X-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion.
  • Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).

Exclusion Criteria:

  • It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
  • It does 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum concentration (Cmax)
Time Frame: up to 4 weeks
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
time to achieve maximum concentration (Tmax)
Time Frame: up to 4 weeks
up to 4 weeks
absorption rate constant (ka)
Time Frame: up to 4 weeks
up to 4 weeks
elimination rate constant (kel)
Time Frame: up to 4 weeks
up to 4 weeks
half-life (t1/2)
Time Frame: up to 4 weeks
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

Investigators

  • Principal Investigator: A-Dong Shen, Master, Beijing Children's Hospital of Capital Medical University, China
  • Principal Investigator: Bao-Ping Xu, MD, Beijing Children's Hospital of Capital Medical University, China; China National Clinical Research Center for Respiratory Diseases

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)

August 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH_PPK001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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