Optimizing Linezolid Dosing in Patients With Advanced Renal Impairment: a Therapeutic Drug Monitoring-based Evaluation

NCT07138521 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Linezolid TDM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to adjust the Linezolid dose according to its blood level in adults with kidney diseases. It will also learn about the safety of linezolid. The main questions it aims to answer are:

• 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.

Conditions

Kidney Disease

Keywords

Linezolid; Therapeutic dose monitoring

Outcome Measures

Primary Outcomes (1)

• Therapeutic range trough targeting

  Linezolid Therapeutic Range Trough Targeting - The proportion of patients whose steady-state linezolid trough concentrations fall within the predefined therapeutic range (e.g., 2-8 mg/L) during treatment as a result of level monitoring and dose correction. This range is the established range for antimicrobial efficacy while minimizing the risk of toxicity, particularly hematological adverse effects. Concentrations will be measured using validated analytical method using HPLC device, and results will be compared to target thresholds to evaluate dosing adequacy.

  From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)

Secondary Outcomes (2)

• Incidence of New-Onset Thrombocytopenia

  From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)

• Correlation Between Linezolid Trough Concentrations and Thrombocytopenia

  From enrollment to the end of antibiotic treatment (typically 10-14 days).

Study Arms (3)

Group 1

EXPERIMENTAL

Linezolid level within therapeutic range

Drug: Linezolid (IV and PO)

Group 2

EXPERIMENTAL

Above the therapeutic range and within the toxicity range

Drug: Linezolid (IV and PO)

Group 3

EXPERIMENTAL

Above the therapeutic range and within the toxicity range

Drug: Linezolid (IV and PO)

Interventions

Linezolid (IV and PO) DRUG

No dose change and continued linezolid 600 mg every 12 hours.

Also known as: 600-twice

Group 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced renal impairment, Hemodialysis patients

You may not qualify if:

• Pregnancy, Lactating females, Advanced Liver impairment, Cases using antidepressants or antipsychotics, Cases suffering from Hematological blood diseases, and/or chronic Immune thrombocytopenia.

Sponsors & Collaborators

• Alexandria University: lead

Related Links

• 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

MeSH Terms

Conditions

Kidney Diseases

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hanaa Said, PharmD, Alexandria University

CONTACT

+201062416139; hanaasaid2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 24, 2025
• Study Start: October 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Start date: Once recruitment is completed and required data is collected. End date: Paper publishing date.
• Access Criteria: Study supervisors and co-researchers will have access for data interpretation and analysis once collected.