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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care; Antibiotics; Severe Burn
• Intervention / Treatment: Diagnostic test: Drug Level Monitoring

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University Hospital Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated on ICU, in group 1 suffering from severe burns, in group 2 without burns

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU Patients with Severe Burns; Patients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam	Diagnostic test: Drug Level Monitoring; 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
ICU Patients without Burns - Drug Level Monitoring; Patient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam	Diagnostic test: Drug Level Monitoring; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Medical Clinic III; Dezernat Apotheke
• Investigators: Study Director: Peter Mailänder, PhD, Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit; Study Chair: Walter Raasch, PhD, Institute for experimental and clinical pharmacology and toxicology; Principal Investigator: Tobias Kisch, MD, Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit

Publications and helpful links

General Publications

• Rafla K, Tredget EE. Infection control in the burn unit. Burns. 2011 Feb;37(1):5-15. doi: 10.1016/j.burns.2009.06.198. Epub 2010 Jun 18.
• Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. doi: 10.2174/138920111798808329.
• Blanchet B, Jullien V, Vinsonneau C, Tod M. Influence of burns on pharmacokinetics and pharmacodynamics of drugs used in the care of burn patients. Clin Pharmacokinet. 2008;47(10):635-54. doi: 10.2165/00003088-200847100-00002.
• Patel BM, Paratz J, See NC, Muller MJ, Rudd M, Paterson D, Briscoe SE, Ungerer J, McWhinney BC, Lipman J, Roberts JA. Therapeutic drug monitoring of beta-lactam antibiotics in burns patients--a one-year prospective study. Ther Drug Monit. 2012 Apr;34(2):160-4. doi: 10.1097/FTD.0b013e31824981a6.
• Olbrisch K, Kisch T, Thern J, Kramme E, Rupp J, Graf T, Wicha SG, Mailander P, Raasch W. After standard dosage of piperacillin plasma concentrations of drug are subtherapeutic in burn patients. Naunyn Schmiedebergs Arch Pharmacol. 2019 Feb;392(2):229-241. doi: 10.1007/s00210-018-1573-6. Epub 2018 Oct 27.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 13-275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No