Bacterial InfectionsNCT03933748
Therapeutic Drug Monitoring of Teicoplanin in Children
An observational study of Bacterial Infections, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Teicoplanin-PMMA
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with gram-positive coccus infection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Ji'nan, Shandong, 250014
Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
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.
- Conditions
- Bacterial Infections
- Being tested
- Teicoplanin-PMMA
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teicoplanin-PMMADrug
Therapeutic drug monitoring of teicoplanin
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration
To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Apr 2019
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Shandong Provincial Hospital, Affiliated Hospital of Qinghai University, Children's Hospital Affiliated to Shandong University, 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 University, Weihai maternal and child health care hospital, The Second Hospital of Shandong University
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933748
- Sponsor's protocol ID
- 2019_Teicoplanin_001
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Teicoplanin in Children
- ClinicalTrials.gov ID
- NCT03933748
- Acronym / sponsor ID
- 2019_Teicoplanin_001
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Shandong Provincial Hospital, Affiliated Hospital of Qinghai University, Children's Hospital Affiliated to Shandong University, 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 University, Weihai maternal and child health care hospital, The Second Hospital of Shandong University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with gram-positive coccus infection
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teicoplanin-PMMATherapeutic drug monitoring of teicoplanin | Drug | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentration (time frame: Through study completion, an average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.