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

Intensive Care Clinical Trial

— MSBV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335137
• Other study ID #: 13-275
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: November 6, 2017
• Start date: May 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics
• Intensive Care
• Severe Burn

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Dezernat Apotheke, Medical Clinic III

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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