Continuous administration of linezolid: improving the dosage of an antibiotic
- Conditions
- InfectionTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-002987-17-ES
- Lead Sponsor
- Helena Barrasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Admitted to the intensive care unit.
Diagnosis of sepsis.
Need to linezolid because of suspected infection due to multiresistant gram positive cocci
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Pregnancy. Age <18 years. Severe renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the pharmacokinetics of linezolid when administered by continuous infusion;Secondary Objective: - To calculate the parameters related to the efficacy and toxicity<br> - To cCompare the results with those obtained after conventional administration;Primary end point(s): To compare the efficacy of two different dosage regimen of linezolid;Timepoint(s) of evaluation of this end point: 4 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To compare the risk of overexposure of two different dosage regimen of linezolid;Timepoint(s) of evaluation of this end point: 4 days