Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060883) titled 'Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Infections requiring treatment with linezolid Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 600

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069668

Disclaimer: Curated by HT Syndication.