The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients
TDM-ICU
1 other identifier
observational
120
1 country
4
Brief Summary
In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 3, 2016
March 1, 2016
9 months
April 24, 2015
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim
3 days
Secondary Outcomes (5)
Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
30 days
The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.
3 days
Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
3 days
SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
3 days
Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
30 days
Interventions
Eligibility Criteria
Intensive care unit patients treated with beta-lactam antibiotics
You may qualify if:
- Current treatment with beta-lactam antibiotics and admission to the ICU
You may not qualify if:
- Pregnancy, age below 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Intensive care unit
Jönköping, Jönköping County, 391 85, Sweden
Intensive Care Unit
Kalmar, Kalmar County, 39185, Sweden
Intensive Care Unit
Linköping, Linköping, 581 85, Sweden
Intensive care unit
Vaxjo, Växjö, 391 85, Sweden
Related Publications (1)
Udy AA, Roberts JA, Lipman J. Clinical implications of antibiotic pharmacokinetic principles in the critically ill. Intensive Care Med. 2013 Dec;39(12):2070-82. doi: 10.1007/s00134-013-3088-4. Epub 2013 Sep 18.
PMID: 24045886BACKGROUND
Biospecimen
Plasma samples at three consecutive days for measurement of plasma drug concentrations
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Schön, MD PhD
Linkoeping University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD (Associate professor)
Study Record Dates
First Submitted
April 24, 2015
First Posted
May 18, 2015
Study Start
October 1, 2014
Primary Completion
July 1, 2015
Study Completion
March 1, 2016
Last Updated
March 3, 2016
Record last verified: 2016-03