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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027535
Receipt No. R000031564
Scientific Title A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Date of disclosure of the study information 2017/06/01
Last modified on 2018/06/06

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Basic information
Public title A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Acronym A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Scientific Title A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Scientific Title:Acronym A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Region
Japan

Condition
Condition Methicillin-resistant Staphylococcus aureus infection
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a high-loading dose regimen of teicoplanin that is more effective for Methicillin-resistant Staphylococcus aureus infection in children by investigating the rate of achieving therapeutic serum trough concentration of teicoplanin in pediatric patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of achieving target serum trough concentration of teicoplanin (more than 15 mg/L) in pediatric patients on the day 3 or 4 of treatment
Key secondary outcomes 1. Rate of achieving target serum trough concentration of teicoplanin (more than 10 mg/L) in pediatric patients on the day 3 or 4 of treatment

2. Incidence of hepatic dysfunction and renal impairment during teicoplanin treatment (AST, ALT, serum creatinine)

3. Resolution of clinically significant signs and symptoms, and mortality on the 4th day of teicoplanin treatment and the day of teicoplanin treatment completion in patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection

4. Duration of fever, and incidence of addition or switching of other anti-MRSA drugs in patients with MRSA infection

5. Duration of bacteremia in patients with MRSA sepsis

6. Relationships between age and concentration (mg/L) /cumulative loading dose per body
weight (mg/kg) (C/D) ratio, serum creatinine level and C/D ratio, and estimated glomerular filtration ratio and C/D ratio

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1. Teicoplanin (15 mg/kg every 12 hours for 3 loading doses followed by 10 mg/kg every 24 hours) is infused intravenously over 1 hour.
2. Serum samples for teicoplanin trough level are obtained just before administration of the 4th or 5th dose, and the dosage of teicoplanin is adjusted according to the serum trough level.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1. Inpatients at the Department of Pediatrics, Kyushu University Hospital

2. Patients receiving teicoplanin treatment for diagnosed or suspected Methicillin-resistant Staphylococcus aureus infection

3. Patients whose written informed consent has been obtained (from them or from their parents)
Key exclusion criteria 1. Patients with renal impairment (serum creatinine is 1.5 times higher than upper limit of normal) and hepatic dysfunction (AST or ALT is 2.5 times higher than upper limit of normal) before teicoplanin treatment

2. Patients with past histories of hypersensitivity reaction against teicoplanin

3. Patients with previous teicoplanin treatment during the previous 7 days

4. Patients with inadequate medical conditions determined by the study director or researchers
Target sample size 42

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shouichi Ohga
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Pediatrics
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5421
Email ohgas@pediatr.med.kyushu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shunsuke Kanno
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Pediatrics
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5421
Homepage URL
Email kannos@pediatr.med.kyushu-u.ac.jp

Sponsor
Institute Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 29 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031564

Research Plan
Registered date File name
2018/06/06 研究計画書UMIN000027535.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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