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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335137
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
Medical Clinic III
Dezernat Apotheke
Information provided by (Responsible Party):
Tobias Kisch, University of Schleswig-Holstein

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
Antibiotics Severe Burn Intensive Care Diagnostic Test: Drug Level Monitoring

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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 : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Burns

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




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 [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
Blood samples are used to determine drug levels of Piperacillin/Tazobactam


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated on ICU, in group 1 suffering from severe burns, in group 2 without burns
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335137


Locations
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Germany
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Schleswig-Holstein
Medical Clinic III
Dezernat Apotheke
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tobias Kisch, Principal Investigator, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03335137    
Other Study ID Numbers: 13-275
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No