Pilot randomised controlled trial of continuous beta-lactam infusion compared with intermittent dosing in critically ill patients
Phase 2
Completed
- Conditions
- Severe sepsisInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12610000238077
- Lead Sponsor
- Beta-Lactam Infusion Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1) Confirmed or suspected infection with new organ dysfunction
2) Commencement within the previous 24 hours or planned commencement of ticarcillin/clavulanate, piperacillin/tazobactam or meropenem
3) Expected or actual ICU stay greater than 48 hours
Exclusion Criteria
1) Allergy or potential allergy to study medications
2) Receiving palliative or supportive treatment only at the time of screening
3) Receiving contrinuous renal replacement therapy
4) No central venous catheter access with 3 or more lumens
5) Receipt of the study drug of interest for > 24 hours prior to enrolment
6) Discharge from the ICU within 48 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pilot study primary outcome: Plasma antibiotic concentration above the Minimum Inhibitory Concentration (MIC) for three samples taken on Days 3 and 4 (dichotomous variable: Yes/No)[Day 3 and 4 post randomisation]
- Secondary Outcome Measures
Name Time Method