UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054268 |
|---|---|
| Receipt number | R000061970 |
| Scientific Title | A study of the relationship between plasma concentrations of linezolid and its relationship with the frequency of adverse events and discontinuation factors. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/04/14 12:35:12 |
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Basic information
Public title
A study of the relationship between plasma concentrations of linezolid and its relationship with the frequency of adverse events and discontinuation factors.
Acronym
A study of the relationship between plasma concentrations of linezolid and its relationship with the frequency of adverse events and discontinuation factors.
Scientific Title
A study of the relationship between plasma concentrations of linezolid and its relationship with the frequency of adverse events and discontinuation factors.
Scientific Title:Acronym
A study of the relationship between plasma concentrations of linezolid and its relationship with the frequency of adverse events and discontinuation factors.
Region
| Japan |
Condition
Condition
infectious disease
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Plasma concentrations of LZD will be measured and evaluated in relation to the incidence of adverse events, history of discontinuation of treatment, and discontinuation factors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the association between plasma concentrations of LZD and incidence of thrombocytopenia and history of dose interruptions and dose interruption factors.
Key secondary outcomes
Differences between the present study in city hospitals and previous reports, mainly in university hospitals, are discussed.
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 18 years of age or older who received linezolid.
Patients diagnosed with an infectious disease requiring linezolid between June 1, 2024 and December 31, 2026.
Patients who give written consent to participate in this study.
Key exclusion criteria
Patients allergic to LZD
Patients with disseminated intravascular coagulation syndrome
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
pharmaceutical department
Zip code
507-8522
Address
5-161 Maehata-cho, Tajimi-shi, Gifu
TEL
0572-22-5311
yamaguchi-daiki@tajimi-hospital.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
pharmaceutical department
Zip code
507-8522
Address
5-161 Maehata-cho, Tajimi-shi, Gifu
TEL
0572-22-5311
Homepage URL
yamaguchi-daiki@tajimi-hospital.jp
Sponsor or person
Institute
Gifu Prefectural Tajimi Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Prefectural Tajimi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Prefectural Tajimi Hospital
Address
5-161 Maehata-cho, Tajimi-shi, Gifu
Tel
0572-22-5311
yamaguchi-daiki@tajimi-hospital.jp
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
岐阜県立多治見病院
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure plasma concentrations of linezolid and evaluate plasma concentrations and incidence of thrombocytopenia, history of dose interruptions, and factors that may lead to dose interruptions.
Management information
Registered date
| 2024 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061970
