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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010759
Receipt No. R000012578
Scientific Title Study of adverse events in patients treated with linezolid and vancomycin (Retrospective study)
Date of disclosure of the study information 2013/05/21
Last modified on 2013/05/19

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Basic information
Public title Study of adverse events in patients treated with linezolid and vancomycin (Retrospective study)
Acronym Study of adverse events in patients treated with linezolid and vancomycin (Retrospective study)
Scientific Title Study of adverse events in patients treated with linezolid and vancomycin (Retrospective study)
Scientific Title:Acronym Study of adverse events in patients treated with linezolid and vancomycin (Retrospective study)
Region
Japan

Condition
Condition Bacterial infections
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the appropriate use of vancomycin or linezolid , relative to the renal dysfunction and thrombocytopenia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence rate of thrombocytopenia and renal dysfunction
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients treated with parenteral vancomycin or linezolid.
Key exclusion criteria Patients had a treatment duration of less than 3 days, were discharged during treatment, or had missing clinical data.
For the renal dysfunction aspect of the study, patients demonstrated end-stage renal failure or were undergoing hemodialysis.
For the thrombocytopenia aspect of the study, patients developed disseminated intravascular coagulation or received a transfusion.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Miyamoto
Organization Sapporo Medical University Hospital
Division name Department of Hospital Pharmacy
Zip code
Address South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Fujii
Organization Sapporo Medical University Hospital
Division name Department of Hospital Pharmacy
Zip code
Address
TEL
Homepage URL
Email fujii.satoshi@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

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
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
2013 Year 05 Month 21 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 Completed
Date of protocol fixation
2011 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2012 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Renal dysfunction occurred significantly more frequently in patients in the vancomycin group (23.5%) than in the linezolid group (13.2%) (p = 0.032). The major risk factor was the vancomycin trough concentration, with significantly more renal dysfunction being observed in patients with trough concentrations over 18.0&micro;g/mL (p < 0.001).
Thrombocytopenia occurred significantly more frequently in linezolid-treated patients (40.6%) than in vancomycin-treated patients (16.9%) (p < 0.001). Duration of linezolid treatment was identified as a major risk factor, with more thrombocytopenia being observed in patients undergoing treatment for over 7.5 days (p = 0.017).

Management information
Registered date
2013 Year 05 Month 19 Day
Last modified on
2013 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012578

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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