Status:

COMPLETED

Drug Monitoring of Antibiotics in Critical Care Patients

Lead Sponsor:

Ludwig-Maximilians - University of Munich

Conditions:

ARDS

Sepsis

Eligibility:

All Genders

18+ years

Brief Summary

Infections are critical factors for the survival of critically ill patients. A broad, high-dose and early initial therapy of antibiotics is of particular relevance. A serious problem is the high vari...

Detailed Description

Substantial variations of serum concentrations of different antibiotics with partly insufficient levels have been observed in critically ill patients. The high variabilities between the pharmacokineti...

Eligibility Criteria

Inclusion

  • Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
  • Presence of infection by clinical assessment
  • Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
  • Bolus administration of selected antibiotics
  • Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.

Exclusion

  • Prophylactic antibiotics without clinical assessment for the presence of infection
  • Planned shorter hospital stay than 4 days
  • Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
  • Only a single dose of an antibiotic per day
  • Subsequent withdrawal of the participation in the study by the patient or the guardian

Key Trial Info

Start Date :

March 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

186 Patients enrolled

Trial Details

Trial ID

NCT01793012

Start Date

March 1 2013

End Date

January 1 2015

Last Update

September 2 2020

Active Locations (1)

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Department of Anaesthesiology of the University Hospital of Munich

Munich, Germany, 81377