NCT03933748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2019

Enrollment Period

6.6 years

First QC Date

April 24, 2019

Last Update Submit

April 11, 2020

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Plasma drug concentration

    To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).

    Through study completion, an average of 14 days

Interventions

Teicoplanin-PMMADRUG

Therapeutic drug monitoring of teicoplanin

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with gram-positive coccus infection

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Interventions

teicoplanin-polymethylmethacrylate bead

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308zhao4wei2@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 1, 2019

Study Start

April 1, 2019

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

April 14, 2020

Record last verified: 2019-04

Locations

CN(1)