UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060883 |
|---|---|
| Receipt number | R000069668 |
| Scientific Title | Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/10 07:20:10 |
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Basic information
Public title
Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study
Acronym
Blood and Saliva-Based Linezolid TDM Study
Scientific Title
Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study
Scientific Title:Acronym
Blood and Saliva-Based Linezolid TDM Study
Region
| Japan |
Condition
Condition
Infections requiring treatment with linezolid
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to generate evidence for the implementation of linezolid therapeutic drug monitoring in clinical practice by conducting a multicenter prospective study evaluating its clinical utility based on blood and salivary concentrations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of thrombocytopenia
Key secondary outcomes
Secondary endpoints include the incidence of severe thrombocytopenia, rate of recovery from thrombocytopenia, rate of linezolid discontinuation due to thrombocytopenia, incidence of other adverse events including anemia and gastrointestinal symptoms, rate of linezolid discontinuation due to other adverse events, treatment completion rate, reasons for discontinuation, clinical cure rate, microbiological response, and relapse rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group: Blood and salivary concentrations will be measured on day 4 after initiation of linezolid therapy, and the results will be fed back to the attending physician.
Interventions/Control_2
Control group: Blood and salivary samples will be collected on day 4 after initiation of linezolid therapy; however, the concentration results will not be fed back to the attending physician, and treatment will be provided under standard care.
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
1) Adult patients with infections requiring treatment with linezolid.
2) Patients from whom written informed consent has been obtained and who are considered by the principal investigator or subinvestigator to be able to comply with the study requirements during participation, undergo the examinations and tests specified in this study protocol, and report their symptoms and other relevant information.
Key exclusion criteria
1) Patients younger than 20 years.
2) Patients with hypersensitivity to linezolid.
3) Patients whose causative microorganism is resistant to linezolid.
4) Patients with a platelet count of less than 50,000/uL prior to initiation of linezolid therapy.
5) Patients with a hemoglobin level of less than 6 g/dL prior to initiation of linezolid therapy.
6) Patients with salivary gland disorders or oral diseases.
7) Patients who are judged by the principal investigator or subinvestigator to be otherwise unsuitable for participation in this study.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yamamoto |
Organization
University of Toyama
Division name
Department of Clinical Infectious Diseases, Faculty of Medicine, Academic Assembly
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama 930-0194, Japan
TEL
076-434-2281
infect@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasuji |
Organization
University of Toyama
Division name
Department of Clinical Infectious Diseases, Faculty of Medicine, Academic Assembly
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama 930-0194, Japan
TEL
076-434-2281
Homepage URL
kawasuji@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japanese Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Morinomiyako Medical Research Foundation
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 Sugitani, Toyama City, Toyama 930-0194, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069668
