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.
COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2007-11-30
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. The intensive care units patients, with mechanical ventilation, and with severe sepsis, represent highly heterogeneous population responsible of hight variability in pharmacokinetics parameters (augmentation in total volume of distribution, modification in glomerular filtration) wich can lead to antibiotic inefficacy.
In a first time, this study describe the pharmacokinetics of Linezolid in intensive care units patients with severe MRSA infection. The aim of this study is to define and validate a population pharmacokinetic model including the influence of patients' characteristic on the pharmacokinetics of Linezolid.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Blood sampling are collected on the second day after beginning of treatment at the following time : H1, H2, H3, H6 and H12.
The population pharmacokinétics analysis will be carried out using Monolix, a software for the analysis of nonlinear mixed effects models.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRSA Infections
Methicillin-Resistant Staphylococcus aureus Infections
Linezolid
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Linezolid
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers
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
* Over 18 years old
* Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be sensitive to Linezolid
* Simplified Acute Physiological Score (SAPS) II \> 20
* Expected duration of life \> 7 days.
Exclusion Criteria
* Isolation of MRSA resistant to linezolid
* Lack of seeds
* Pregnancy and lactation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bernard Georges, PhMD
Role: PRINCIPAL_INVESTIGATOR
UH Toulouse
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06 049 02
Identifier Type: -
Identifier Source: org_study_id