UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027535 |
|---|---|
| Receipt number | 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 18:41:48 |
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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
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
ohgas@pediatr.med.kyushu-u.ac.jp
Public contact
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
kannos@pediatr.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
