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

NCT07138521 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-24

No results posted yet for this study

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

Interventions

DRUG

Linezolid (IV and PO)

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

DRUG

Linezolid (IV and PO)

Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours.

DRUG

Linezolid (IV and PO)

Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2025-12-15
Completion
2026-05-15
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138521 on ClinicalTrials.gov