Pk/Pd aspects of linezolid in critically ill patients with late onset Ventilator-Associated Pneumonia. Intermittent versus Continuous Infusion Introduction - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023683-41-IT

Enrollment

Registered

2010-12-24

Start date

2011-04-21

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventilator associated pneumoniae MedDRA version: 9.1 Level: LLT Classification code 10060946

Interventions

Trade Name: ZYVOXID Pharmaceutical Form: Solution for infusion INN or Proposed INN: Linezolid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026