Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study

Clinical Utility of Linezolid Therapeutic Drug Monitoring Based on Blood and Salivary Concentrations: An Open-Label, Randomized, Multicenter, Prospective Interventional Study - Blood and Saliva-Based Linezolid TDM Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060883

Enrollment

600

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections requiring treatment with linezolid

Interventions

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. Control group: Blood

however, the concentration results will not be fed back to the attending physician, and treatment will be provided under standard care.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Incidence of thrombocytopenia	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactHitoshi Kawasuji

University of Toyama Department of Clinical Infectious Diseases, Faculty of Medicine, Academic Assembly

kawasuji@med.u-toyama.ac.jp076-434-2281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026