Pk/Pd aspects of linezolid in critically ill patients with late onset Ventilator-Associated Pneumonia. Intermittent versus Continuous Infusion Introduction - ND
- Conditions
- ventilator associated pneumoniaeMedDRA version: 9.1Level: LLTClassification code 10060946
- Registration Number
- EUCTR2010-023683-41-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
all critically ill adult patients who are mechanically ventilated in Intensive Care Unit (ICU) for more than 96 hours developing VAP (CPIS value=6 or new and persistent infiltrate on chest radiography without another obvious cause associated with any two of the following conditions: purulent tracheal secretions, temperature of 38.?C or higher, leukocyte count higher than 11000/µL or lower than 3500/µL, increasing oxygen requirements, recent finding of pathogenic bacteria from respiratory secretions). Anuric patients can be enrolled if they are yet receiving CVVHDF.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•are < 18 years
•are pregnant
•are allergic to linezolid
•have creatinine clereance ClCR <40 ml/min (calculated according to Cocrockft-Gault formula), with the exception of anuric ones undergoing CVVHDF
•present thrombocytopenia (platelets count<80000/mmc)
•have severe hepatic failure (Child-Pugh C)
•have little chance of survival as defined by Symplified Acute Physiology Score (SAPS II)
•are treated with other drugs that can potentially interfere with linezolid (i.e. erythromycin, serotonin modulators).
•Absence of infromed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This is an open-label, randomized, parallel group, prospective trial aimed to verify if linezolid administration by continuous infusion can maximize pk/pd parameters (Tfree>MIC, AUC/MIC, ELF/serum penetration ratio, Cmax, Cmin, Vd, CLR, CLCVVHDF, T1/2 ) compared with traditional intermittent modality ,in patients affected by late-onset VAP including those ones anuric, undergoing CVVHDF.;Secondary Objective: Clinical outcome and adverse effects are also recorded;Primary end point(s): pharmacokinetics
- Secondary Outcome Measures
Name Time Method