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The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02446392
Acronym
TDM-ICU
Enrollment
120
Registered
2015-05-18
Start date
2014-10-31
Completion date
2016-03-31
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

OTHERNo intervention.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Current treatment with beta-lactam antibiotics and admission to the ICU

Exclusion criteria

* Pregnancy, age below 18 years

Design outcomes

Primary

MeasureTime frame
The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim3 days

Secondary

MeasureTime frame
Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome30 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 outcome3 days
SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome3 days
Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome30 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026