NCT03933748RecruitingNot Applicable
Therapeutic Drug Monitoring of Teicoplanin in Children
Shandong University1 site in 1 country500 target enrollmentStarted: April 1, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Plasma drug concentration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University
Study Sites (1)
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