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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028437
Receipt No. R000032554
Scientific Title Efficancy and safety of dosage adjustments for linezolid in patients with renal impairment
Date of disclosure of the study information 2017/10/01
Last modified on 2017/07/29

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Basic information
Public title Efficancy and safety of dosage adjustments for linezolid in patients with renal impairment
Acronym dosage adjustments for linezolid
Scientific Title Efficancy and safety of dosage adjustments for linezolid in patients with renal impairment
Scientific Title:Acronym dosage adjustments for linezolid
Region
Japan

Condition
Condition Infectious disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Reduce of linezolid-associated thrombocytopenia by the dose adjustment based on Therapeutic Drug Monitoring
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes assessment of thrombocytopenia
Key secondary outcomes

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 linezolid dose adjustment on Therapeutic Drug Monitoring
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 adult patients after providing informed consent received linezolid from October 2017 to December 2021 at Kitasato University Hospital (Kanagawa,Japan).
Key exclusion criteria 1)allergy to linezolid
2)disseminated intravascular coagulation
3)thrombocytopenia before linezolid treatment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Komatsu
Organization Kitasato University Hospital
Division name Department of Pharmacy
Zip code
Address 1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa, Japan,
TEL (+81)42-778-8111
Email t.komatu@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Komatsu
Organization Kitasato University Hospital
Division name Department of Pharmacy
Zip code
Address 1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa, Japan,
TEL (+81)42-778-8111
Homepage URL
Email t.komatu@kitasato-u.ac.jp

Sponsor
Institute Kitasato University Hospital
Institute
Department

Funding Source
Organization Kitasato University Hospital
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 10 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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 07 Month 29 Day
Last modified on
2017 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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