Optimizing Linezolid Dosing in Patients With Advanced Renal Impairment: a Therapeutic Drug Monitoring-based Evaluation
NCT ID: NCT07138521
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-10-15
2026-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* How often does linezolid require level monitoring?
* How often does linezolid require dose adjustment?
* What medical benefits do participants have when linezolid level monitoring is applied? Researchers will compare two dose reduction regimens when they have evidence of overexposure to determine which regimen is more effective in preventing thrombocytopenia (Platelet drop).
Participants will:
* Withdrew linezolid level every 2 to 4 days of the antibiotic course.
* Visit the clinic twice for checkups and tests.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)
NCT02087566
Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)
NCT00780351
Effects of Renin-Angiotensin System Inhibitors in Peritoneal Dialysis Patients
NCT04076930
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
NCT02287493
Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis
NCT00417339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recently, Linezolid usage has become favorable for chronic kidney disease (CKD) patients to preserve the remaining residual renal function by avoiding nephrotoxic antibiotics such as vancomycin and aminoglycosides. However, linezolid-induced thrombocytopenia hinders linezolid use in the CKD population due to accumulation and overexposure. Recent literature suggested implementing a therapeutic drug monitoring (TDM) approach to modify the dose regimen and minimize linezolid toxicity.
The obstacle faced was the lack of clear TDM-based linezolid modification guidelines for CKD patients. To overcome this issue, we conducted a pilot study involving 15 patients (7 ESRD, 5 CKD, and 3 AKI on top of CKD). Patients with evidence of toxic levels (8 patients) underwent dose adjustment from 600mg every 12 hours to 300mg every 12 hours.
Dose reduction by 50% with no change in dose interval resulted in a decrease in supratherapeutic trough levels. However, these levels, while lower, did not consistently reach the predefined target therapeutic range (2-8 mg/dl).
The recent approach we are investigating now is to both lower the dose and elongate the interval.
The aim of the work is to optimize renal dosing adjustment with patients having linezolid by investigating whether once-daily dosing administration of linezolid provides better trough-range targeting over twice-daily targeting.
Research Steps
1. Patients were interviewed and selected according to the study's selection criteria.
2. Blood tests were taken before the start of the study to assess their condition and record their medical history before starting linezolid treatment.
3. Participants were divided into three groups based on linezolid drug concentrations compared to the pre-defined target therapeutic range, as determined by the pharmacotherapy monitoring guidelines:
I. Group 1: Within the therapeutic range: No intervention and continued linezolid 600 mg every 12 hours.
II. Group 2: Above the therapeutic range and within the toxicity range: Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours.
III. Group 3: Above the therapeutic range and within the toxicity range: Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours.
4. Patient follow-up was conducted at the end of the study and comparisons were made between the different groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Linezolid level within therapeutic range
Linezolid (IV and PO)
No dose change and continued linezolid 600 mg every 12 hours.
Group 2
Above the therapeutic range and within the toxicity range
Linezolid (IV and PO)
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours.
Group 3
Above the therapeutic range and within the toxicity range
Linezolid (IV and PO)
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Linezolid (IV and PO)
No dose change and continued linezolid 600 mg every 12 hours.
Linezolid (IV and PO)
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours.
Linezolid (IV and PO)
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexandria University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Dose optimisation of linezolid in critically ill patients based on a population pharmacokinetic model: A two-centre prospective interventional study
Pharmacokinetics of Linezolid Dose Adjustment for Creatinine Clearance in Critically Ill Patients: A Multicenter, Prospective, Open-Label, Observational Study
Dosage Strategy of Linezolid According to the Trough Concentration Target and Renal Function in Chinese Critically Ill Patients
Reappraisal of Linezolid Dosing in Renal Impairment To Improve Safety
Analysis of thrombocytopenic effects and population pharmacokinetics of linezolid: a dosage strategy according to the trough concentration target and renal function in adult patients
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Linezolid TDM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.