Antibiotic Pharmacokinetics in Critically Ill Patients
Overview
- Phase
- Not Applicable
- Intervention
- Linezolid
- Conditions
- Critical Illness
- Sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Enrollment
- 1500
- Locations
- 11
- Primary Endpoint
- Drug plasma concentration (time-dependent antibiotics)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project.
For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin.
- •patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU.
- •patients with anticipated length of stay in ICU of at least 24h.
- •patients with already-placed catheter
Exclusion Criteria
- •patients undergoing antibiotic prophylaxis
- •lack of informed consent
Arms & Interventions
linezolid
patients treated with linezolid
Intervention: Linezolid
meropenem
patients treated with meropenem
Intervention: Meropenem
piperacillin/tazobactam
patients treated with piperacillin/tazobactam
Intervention: Piperacillin-tazobactam combination product
vancomycin
patients treated with vancomycin
Intervention: Vancomycin
Outcomes
Primary Outcomes
Drug plasma concentration (time-dependent antibiotics)
Time Frame: 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment
Drug plasma concentration (concentration-dependent antibiotics)
Time Frame: 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy