Evaluation Of Linezolid Pk Profile In Burns Patients

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of linezolid pk profile in burns patients

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia

NCT01805284

Pneumonia

COMPLETED PHASE4

Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia

NCT04531332

Pneumonia

UNKNOWN NA

Population Pharmacokinetics of Linezolid

NCT01200654

Methicillin-Resistant Staphylococcus AureuS

COMPLETED PHASE4

The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

NCT00811980

Sepsis

COMPLETED

Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

NCT01561469

Methicillin-Resistant Staphylococcus Aureus (MRSA) Hospital-Acquired Pneumonia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

linezolid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject with a Body Mass Index (BMI) \< 30 kg/m\². For patient with major thermal injuries, the weight will be collected before the burn ;
* Patients with major thermal injuries \>40% body area including 3rd degree burns with full thickness burns ;
* Patients hospitalized for at least 10 days since their thermal injury occurred ;

Exclusion Criteria

* Contra-indications to use linezolid as mentioned in the SmPC (Summarized Product Characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ;
* Drugs metabolised by monoamine oxydase (MAO) should be evaluated for potential drug-to-drug interaction;
* Subject treated by: selective serotonin reuptake inhibitors (Prozac\®, Effexor\®, Ixel\® \), tricyclic antidepressant (Anafranil\®, Sinequan\®, Surmontil\®, Tofranil\®), 5HT1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes