Clinical trial NCT03335137: Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
Official title: Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotics
Severe Burn
Intensive Care
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Medical Clinic III
name: Dezernat Apotheke
First posted: 2017-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated on ICU, in group 1 suffering from severe burns, in group 2 without burns

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
name: Peter Mailänder, PhD
role: STUDY_DIRECTOR
affiliation: Institute for experimental and clinical pharmacology and toxicology
name: Walter Raasch, PhD
role: STUDY_CHAIR
affiliation: Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.
citation: 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.