EUCTR2017-004637-85-BEActive, not recruitingPhase 1
A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients - The Beta-Lactam InfusioN Group (BLING) III study
The George Institute for Global Health0 sites7,600 target enrollmentStarted: November 26, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 7,600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patient has a documented site of infection or strong suspicion of infection
- •2. Patient is expected to be in the ICU the day after tomorrow
- •3. Patient has been commenced on piperacillin-tazobactam or meropenem to treat the episode of infection
- •4. Giving piperacillin-tazobactam or meropenem by intermittent infusion or continuous infusion is considered equally appropriate for the patient
- •5. One or more organ dysfunction criteria in the previous 24 hours
- •i. MAP < 60 mmHg for at least 1 hour
- •ii. Vasopressors required for > 4 hours
- •iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour
- •iv. Serum creatinine concentration > 220 µmol/L or >2.49 mg/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
Exclusion Criteria
- •1. Patient age is less than 18 years
- •2. Patient has received piperacillin-tazobactam or meropenem for more than 24 hours during current infectious episode
- •3. Patient is known or suspected to be pregnant
- •4. Patient has a known allergy to piperacillin-tazobactam, meropenem or penicillin
- •5. Patient is requiring renal replacement therapy at the time of randomisation, including renal replacement therapy for chronic renal failure
- •6. The attending physician or patient or surrogate legal decision maker is not committed to advanced life-support, including mechanical ventilation, dialysis and vasopressor administration, for at least the next 48 hours
- •7. Patient’s death is deemed imminent and inevitable
- •8. Patient has previously been enrolled in BLING III
Investigators
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