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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


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

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

- 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

Contacts and Locations

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


China, Shandong
Shandong Provincial Qianfoshan Hospital

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
  • 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