UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010759 |
|---|---|
| Receipt number | 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 22:45:21 |
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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
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
fujii.satoshi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical 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
| 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 18.0µg/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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012578
