Does guideline-based dosing of beta lactam antibiotics and vancomycin achieve the target drug concentrations more than therapeutic drug monitoring-based dosing in critically ill patients? (GUIDE TRIAL)
- Conditions
- SepsisSerious infectionInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12619000693123
- Lead Sponsor
- Paul Williams
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
• Written informed consent obtained from the patient or their legally authorised representative
• Aged 18 years or over
• Patient is an inpatient of the ICU
• Patient prescribed at least one of the study antibiotics to treat an infection
• Prescribed flucloxacillin, cefepime, piperacillin/tazobactam, meropenem or vancomycin
via a continuous or intermittent dosing regimen
• Suitable intravenous/intra-arterial access to facilitate sample collection
• Consent not obtained
• Aged less than 18 years
• Not being administered any of the study antibiotics
• Study antibiotics have been administered for greater than 72 hours prior to enrolment
• Limited or no intravenous/intra-arterial access.
• Known to be pregnant
• Prophylactic antibiotics
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether locally endorsed guideline based antibiotic dosing achieves pharmacodynamic target attainment of 100% fT>MIC for beta lactam antibiotics, or a steady state trough concentration of 15-20mg/L for vancomycin in critically ill patients.<br><br>The concentration of the study antibiotics in the biological blood samples will be determined by chromatographic methods (HPLC and LC-MS/MS)[The drug concentrations will be measured at 4 time points.<br>2 samples taken during day 1-3 of therapy, and 2 samples taken on day 4-6 of therapy]
- Secondary Outcome Measures
Name Time Method