Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.

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Key information

Conditions

Antibiotics Burns Intensive Care Severe Burn Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General

Adult
Receiving beta-lactam antibiotic Piperacillin/Tazobactam
Antibiotic therapy of 3 or more days
Given informed consent Group 1
Severe Burn Group 2
No Severe Burn

Exclusion criteria

Already in another Study
No useful blood sample

Treatment and study plan

Drug Level Monitoring

Diagnostic Test

Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission

Primary outcomes

Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission

Time frame: 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission

Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

Dezernat Apotheke
Medical Clinic III

Registry information

Acronym: MSBV

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 7, 2017
Registry last updated: Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed