NCT03335137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

October 24, 2017

Last Update Submit

November 6, 2017

Conditions

AntibioticsSevere BurnIntensive Care

Outcome Measures

Primary Outcomes (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

    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

Study Arms (2)

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

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

Interventions

Drug Level MonitoringDIAGNOSTIC_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

ICU Patients with Severe BurnsICU Patients without Burns - Drug Level Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Already in another Study
  • No useful blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (5)

  • 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.

    PMID: 20561750BACKGROUND

  • 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.

    PMID: 21554211BACKGROUND

  • 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.

    PMID: 18783295BACKGROUND

  • 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.

    PMID: 22406650BACKGROUND

  • 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.

    PMID: 30368548DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are used to determine drug levels of Piperacillin/Tazobactam

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Peter Mailänder, PhD

    Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit

    STUDY DIRECTOR

  • Walter Raasch, PhD

    Institute for experimental and clinical pharmacology and toxicology

    STUDY CHAIR

  • Tobias Kisch, MD

    Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 7, 2017

Study Start

May 1, 2014

Primary Completion

May 31, 2016

Study Completion

December 31, 2016

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)