Skip to main content
Clinical Trials/NCT02609646
NCT02609646
Completed
Not Applicable

Antibiotic Pharmacokinetics in Critically Ill Patients

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva11 sites in 1 country1,500 target enrollmentJanuary 2016

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
June 26, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Responsible Party
Sponsor

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

Study Sites (11)

Loading locations...

Similar Trials