Kidney DiseasePhase 4NCT07138521
Optimizing Linezolid Dosing in Patients With Advanced Renal Impairment: a Therapeutic Drug Monitoring-based Evaluation
A Phase 4 study testing Linezolid (IV and PO) in people with Kidney Disease, run by Alexandria University.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Linezolid (IV and PO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 15 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced renal impairment, Hemodialysis patients
Who cannot join
- Pregnancy, Lactating females, Advanced Liver impairment, Cases using antidepressants or antipsychotics, Cases suffering from Hematological blood diseases, and/or chronic Immune thrombocytopenia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
Participants will:
- Withdrew linezolid level every 2 to 4 days of the antibiotic course.
- Visit the clinic twice for checkups and tests.
Read the detailed description
Linezolid is a crucial antibiotic prescribed for the treatment of various infectious diseases such as pneumonia, skin infections, and catheter-related bloodstream infections. Linezolid covers gram-positive bacteria, including Methicillin-resistant Staphylococcus Auris (MRSA) and Vancomycin-resistant Staphylococcus Auris (VRSA).
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
- Patients were interviewed and selected according to the study's selection criteria.
- Blood tests were taken before the start of the study to assess their condition and record their medical history before starting linezolid treatment.
- 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:
- 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.
- Patient follow-up was conducted at the end of the study and comparisons were made between the different groups.
- Conditions
- Kidney Disease
- Being tested
- Linezolid (IV and PO)
- Keywords
- Linezolid, Therapeutic dose monitoring
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linezolid (IV and PO)Drug
Also called 600-twice
No dose change and continued linezolid 600 mg every 12 hours.
Linezolid (IV and PO)Drug
Also called 300-twice
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours.
Linezolid (IV and PO)Drug
Also called 600-once
Intervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Linezolid level within therapeutic range Receives: Drug: Linezolid (IV and PO) |
| Group 2 | Experimental | Above the therapeutic range and within the toxicity range Receives: Drug: Linezolid (IV and PO) |
| Group 3 | Experimental | Above the therapeutic range and within the toxicity range Receives: Drug: Linezolid (IV and PO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)
Secondary outcomes (2)
Incidence of New-Onset Thrombocytopenia
Proportion of participants (Unit of Measure: % of participants) who develop new-onset thrombocytopenia during linezolid therapy, defined as a platelet count <150 × 10⁹/L or a ≥25% reduction from baseline, whichever is lower.
Platelet counts (× 10⁹/L) will be monitored at baseline and predetermined intervals throughout therapy and obtained through routine laboratory testing.
Measured: From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)
Correlation Between Linezolid Trough Concentrations and Thrombocytopenia
Correlation analysis of linezolid trough concentrations with thrombocytopenia occurrence: The measurement tools are plasma trough concentration of linezolid (mg/L, measured by validated HPLC) and platelet count (× 10⁹/L, measured by routine laboratory testing). The relationship will be assessed using correlation coefficient (r) calculations.
Measured: From enrollment to the end of antibiotic treatment (typically 10-14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138521
- Sponsor's protocol ID
- Linezolid TDM
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Variables including: Age, Weight, Gender, Blood workups, such as Platelets count and Linezolid blood levels.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Linezolid Dosing in Patients With Advanced Renal Impairment: a Therapeutic Drug Monitoring-based Evaluation
- ClinicalTrials.gov ID
- NCT07138521
- Acronym / sponsor ID
- Linezolid TDM
- Conditions
- Kidney Disease
- Keywords
- Linezolid, Therapeutic dose monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Linezolid is a crucial antibiotic prescribed for the treatment of various infectious diseases such as pneumonia, skin infections, and catheter-related bloodstream infections. Linezolid covers gram-positive bacteria, including Methicillin-resistant Staphylococcus Auris (MRSA) and Vancomycin-resistant Staphylococcus Auris (VRSA).
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
- Patients were interviewed and selected according to the study's selection criteria.
- Blood tests were taken before the start of the study to assess their condition and record their medical history before starting linezolid treatment.
- 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:
- 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.
- Patient follow-up was conducted at the end of the study and comparisons were made between the different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Linezolid (IV and PO)Linezolid level within therapeutic range |
| Group 2 | Experimental | Drug: Linezolid (IV and PO)Above the therapeutic range and within the toxicity range |
| Group 3 | Experimental | Drug: Linezolid (IV and PO)Above the therapeutic range and within the toxicity range |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced renal impairment, Hemodialysis patients
Key exclusion criteria (1 listed)
- Pregnancy, Lactating females, Advanced Liver impairment, Cases using antidepressants or antipsychotics, Cases suffering from Hematological blood diseases, and/or chronic Immune thrombocytopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linezolid (IV and PO)Also: 600-twiceNo dose change and continued linezolid 600 mg every 12 hours. | Drug | Group 1 |
| Linezolid (IV and PO)Also: 300-twiceIntervention and adjustment of the linezolid dose from 600 mg every 12 hours to 300 mg every 12 hours. | Drug | Group 2 |
| Linezolid (IV and PO)Also: 600-onceIntervention and adjustment of the linezolid dose from 600 mg every 12 hours to 600 mg every 24 hours. | Drug | Group 3 |
Primary outcome
Therapeutic range trough targeting
Time frame: From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)
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.
2 secondary outcomes
Incidence of New-Onset Thrombocytopenia
Time frame: From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)
Correlation Between Linezolid Trough Concentrations and Thrombocytopenia
Time frame: From enrollment to the end of antibiotic treatment (typically 10-14 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Dose optimisation of linezolid in critically ill patients based on a population pharmacokinetic model: A two-centre prospective interventional studyLink provided by the sponsor.
- Pharmacokinetics of Linezolid Dose Adjustment for Creatinine Clearance in Critically Ill Patients: A Multicenter, Prospective, Open-Label, Observational StudyLink provided by the sponsor.
- Dosage Strategy of Linezolid According to the Trough Concentration Target and Renal Function in Chinese Critically Ill PatientsLink provided by the sponsor.
- Reappraisal of Linezolid Dosing in Renal Impairment To Improve SafetyLink provided by the sponsor.
- Analysis of thrombocytopenic effects and population pharmacokinetics of linezolid: a dosage strategy according to the trough concentration target and renal function in adult patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Variables including: Age, Weight, Gender, Blood workups, such as Platelets count and Linezolid blood levels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linezolid (IV and PO) in people with Kidney Disease, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanaa Said, PharmD, Alexandria University (+201062416139, hanaasaid2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic range trough targeting (time frame: From enrollment to the end of antibiotic treatment duration (typically 10 to 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.