UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052478 |
|---|---|
| Receipt number | R000059894 |
| Scientific Title | Studies on the relationship between plasma concentrations of linezolid and its efficacy and thrombocytopenia |
| Date of disclosure of the study information | 2023/10/13 |
| Last modified on | 2023/10/12 17:43:21 |
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Basic information
Public title
Studies on the relationship between plasma concentrations of linezolid and its efficacy and thrombocytopenia
Acronym
Studies on the relationship between plasma concentrations of linezolid and its efficacy and thrombocytopenia
Scientific Title
Studies on the relationship between plasma concentrations of linezolid and its efficacy and thrombocytopenia
Scientific Title:Acronym
Studies on the relationship between plasma concentrations of linezolid and its efficacy and thrombocytopenia
Region
| Japan |
Condition
Condition
infectious disease
Classification by specialty
| Infectious disease | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Plasma concentrations of LZD are measured, and LZD dosage is adjusted based on these plasma concentrations and renal function to minimize the occurrence of LZD-induced thrombocytopenia and to ensure that treatment with LZD is continued.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment efficacy (duration of LZD treatment, treatment completion rate, clinical improvement rate of infection) and incidence of adverse events (thrombocytopenia) when dose adjustment is performed based on LZD plasma concentration
Key secondary outcomes
Association of LZD plasma concentrations with LZD dose adjustment rate, treatment efficacy, and adverse event occurrence by measuring plasma concentrations
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
Three to five days after the start of linezolid administration, blood should be drawn to measure plasma concentrations, and the dose should be changed (either continued at the current dose or reduced) based on the plasma concentrations obtained and renal function.
Plasma concentrations should be measured at least once a week to monitor plasma concentration trends.
Dosing should be continued until treatment of infection is completed.
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 treated with LZD
Patients diagnosed with an orthopedic infection between September 1, 2023 and September 31, 2025
Patients with written consent to participate in this study
Key exclusion criteria
Patients allergic to LZD
Patients with disseminated intravascular coagulation syndrome
Target sample size
10
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
| 2023 | Year | 10 | Month | 13 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059894
