About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Therapeutic Drug Monitoring of Teicoplanin in Children

Clinicaltrials.gov identifier NCT03933748

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted April 14, 2020

Study Description

Brief summary:

In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.

  • Condition or Disease:Bacterial Infections
  • Intervention/Treatment: Drug: Teicoplanin-PMMA
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 500 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Therapeutic Drug Monitoring of Teicoplanin in Children
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: November 2025
  • Estimated Study Completion Date: December 2025
Outcome Measures
  • Primary Outcome Measures: 1. Plasma drug concentration [ Time Frame: Through study completion, an average of 14 days ]
    To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).
Eligibility Criteria
  • Ages Eligible for Study: up to 18 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Children with gram-positive coccus infection
Criteria

Inclusion Criteria:

- Teicoplanin was administered intravenously;

- Teicoplanin was used for therapeutic purposes;

- Age:≤18 years;

- Clinician confirms and plans to diagnose the patient with gram-positive coccus
infection;

- Patients with therapeutic concentration monitoring of teicoplanin.

Exclusion Criteria:

- Teicoplanin was administered non-intravenously;

- Teicoplanin was used for prophylactic purposes;

- Patients without therapeutic concentration monitoring of teicoplanin;

- Patients who die within 24 hours of the use of teicoplanin;

- The blood concentrations of the patient was not approved by the quality control
center.

Contacts and Locations
Contacts

Contact: Wei Zhao, Ph.D 86053188383308 zhao4wei2@hotmail.com

Locations

China, Shandong
Shandong Provincial Qianfoshan Hospital
Ji'nan

Sponsors and Collaborators

Shandong University

Qianfoshan Hospital

Shandong Provincial Hospital

Affiliated Hospital of Qinghai University

Jinan children's hospital

Yantai Yuhuangding Hospital

Jinan Central Hospital

Liaocheng People's Hospital

Shandong Tumor Hospital

Weifang People's Hospital

Linyi People's Hospital

Affiliated hospital of jining medical college

Weihai maternal and child health care hospital

The Second Hospital of Shandong University

More Information
  • Responsible Party: Shandong University
  • ClinicalTrials.gov Identifier: NCT03933748 History of Changes
  • Other Study ID Numbers: 2019_Teicoplanin_001
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: April 14, 2020
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Bacterial Infections