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

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Completed
• CT.gov ID: NCT03335137
• Collaborator: Medical Clinic III (Other), Dezernat Apotheke (Other)
• Enrollment: 35
• Location: 1
• Actual Duration (Months): 32
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Antibiotics; Severe Burn; Intensive Care	Diagnostic Test: Drug Level Monitoring

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein	Germany	23538

Sponsors and Collaborators

• University Hospital Schleswig-Holstein
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.
• 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. Review.
• Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. Review.

• Responsible Party: Tobias Kisch, Principal Investigator, University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT03335137
• Other Study ID Numbers: 13-275
• First Posted: Nov 7, 2017
• Last Update Posted: Nov 7, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 7, 2017