UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004321 |
|---|---|
| Receipt number | R000005178 |
| Scientific Title | Pharmacokinetics of linezolid in subjects with renal dysfunction and ones under dialysis; an open-label,non-randomized study |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2023/05/30 08:12:29 |
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Basic information
Public title
Pharmacokinetics of linezolid in subjects with renal dysfunction and ones under dialysis; an open-label,non-randomized study
Acronym
Pharmacokinetics of linezolid in subjects with renal dysfunction and under dialysis
Scientific Title
Pharmacokinetics of linezolid in subjects with renal dysfunction and ones under dialysis; an open-label,non-randomized study
Scientific Title:Acronym
Pharmacokinetics of linezolid in subjects with renal dysfunction and under dialysis
Region
| Japan |
Condition
Condition
MRSA infection
Classification by specialty
| Infectious disease | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjects recruited into 4 groups on the basis of their estimated GFR. To investigate the pharmacokinetics of linezolid, blood and urine samples are assayed after intravenous administration of linezolid.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetic parameters of linezolid in subjects with renal dysfunction and ones under dialysis
Key secondary outcomes
Blood concentration-time profile of linezolid and major metabolites, and those of urinary extraction amounts in patients, the efficacy and safety of linezolid in patients with renal dysfunction, including patients receiving renal replacement therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects are recruited into 4 groups on the basis of their estimated GFR. All patients received a dose of 600 mg linezolid every 12h intravenously. To investigate the pharmacokinetics of linezolid, blood and urine samples are assayed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) age, 20 years or higher
2) MRSA infections, including suspicions
3) inpatients at intensive care unit
4) prescribed blood sampling were available
5) gave their or their relatives' written informed consent
Key exclusion criteria
1) history of hypersensitivity to ZYVOX
2) pregnancy, parturition or lactation
3) other situation that doctor decides
4) switch to orally administration of linezolid
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Sai |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
13-1 Takara-machi, Kanazawa 920-8641
TEL
076-265-2000
sai-ys@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Sai |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
13-1 Takara-machi, Kanazawa 920-8641
TEL
076-265-2046
Homepage URL
sai-ys@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000005178
Publication of results
Partially published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=cl5tdmke/2011/002803/039&name=5142-514
Number of participants that the trial has enrolled
7
Results
LZD and its metabolites could accumulate with repeated dosing during continuous hemodiafiltration in patients with acute renal failure.
Results date posted
| 2023 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Two patients infected by MRSA, receiving CHDF due to acute renal failure.
Participant flow
Patients received a dose of 600 mg linezolid every 12h intravenously, due to MRSA infection.
Adverse events
none
Outcome measures
Pharmacokinetic parameters of linezolid in subjects with renal dysfunction and ones under dialysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
