Therapeutic Drug Monitoring of Teicoplanin in Children

NCT ID: NCT03933748

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Teicoplanin-PMMA

Therapeutic drug monitoring of teicoplanin

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role collaborator

Jinan children's hospital

UNKNOWN

Sponsor Role collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role collaborator

Jinan Central Hospital

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Shandong Tumor Hospital

OTHER

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

Weihai maternal and child health care hospital

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D

Role: CONTACT

86053188383308

Facility Contacts

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Wei Zhao, Ph.D

Role: primary

86053188383308

Other Identifiers

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2019_Teicoplanin_001

Identifier Type: -

Identifier Source: org_study_id

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