Sepsis MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Piperacilline-Tazobactam
Product Name: Piperacilline/Tazobactam
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PIPERACILLIN SODIUM
CAS Number: 59703-84-3
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Sponsors
The George Institute for Global Health
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether continuous infusion of a beta-lactam antibiotic (piperacillin-tazobactam or meropenem) results in decreased all-cause Day 90 mortality compared with intermittent beta-lactam antibiotic infusion in critically ill patients with sepsis.;Secondary Objective: Not applicable;Primary end point(s): All-cause mortality within 90 days after randomisation.;Timepoint(s) of evaluation of this end point: 90 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical cure at Day 14 post randomisation 2. New acquisition, colonisation or infection with an multi-resistant organism (MRO) or Clostridium difficile diarrhoea up to 14 days post randomisation 3. All-cause ICU mortality 4. All-cause hospital mortality;Timepoint(s) of evaluation of this end point: 1. 14 days post randomisation 2. 14 days post randomisation 2. 90 days post randomisation 2. 90 days post randomisation | — |
Countries
Australia, Belgium, France, Italy, New Zealand, Portugal, Sweden, United Kingdom
Contacts
Public ContactHIRUZ
University Hospital Ghent
Outcome results
None listed