Individualising beta-lactam antibiotic dosing in septic intensive care unit patients based on plasma concentration measurements using therapeutic drug monitoring
Not Applicable
- Conditions
- Beta-lactam antibiotic dosing in sepsisInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12623000032651
- Lead Sponsor
- The Alfred
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
1.Aged 18 years or over, admitted to the ICU
2.Bacterial infection considered highly likely
3.Informed consent is obtained from the patient or their surrogate decision maker
4.A study beta-lactam has been prescribed and at least four doses have been administered
Exclusion Criteria
1.Pregnancy/lactation
2.Imminent death (within 24 hours)
3.Study enrolment deemed inappropriate by treating clinician
4.Hypersensitivity to beta-lactam antibiotics
5.Treatment commenced more than 24 hours prior to randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test the feasibility of recruitment (number of participants recruited from pool of eligible participants)<br>The pool of eligible participants will be determined by audit of study recruitment log.[At the end of the six month study period.];To test the feasibility of randomisation (number of participants randomised from pool of participants eligible for randomisation - determined by audit of study recruitment log)<br>[At the end of the 6-month study period.];To test the fidelity of TDM (the degree to which TDM is delivered as intended - accurate timing of sampling and availability of results within 4 - 6 hours of sampling. This will be assessed as a composite outcome.<br>Via chart audit. [Daily assessment from 24-hours post commencement of antibiotic therapy to cessation of antibiotic therapy. <br>]
- Secondary Outcome Measures
Name Time Method