Critical illness, ventilator associated pneumonia MedDRA version: 14.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia System Organ Class: 100000004862
Conditions
Interventions
Product Name: Piperacillin/tazobactam
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: piperacillin
Concentration unit: g gram(s)
Concentration type: equal
Conce
Sponsors
University Hospital of South Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is an adult aged 18 to 85 2. Subject requires or has been commenced on piperacillin/tazobactam as directed by clinical Intensive Care Unit medical staff Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Subject is known to be intolerant of ß-lactams antibiotics 2. Subject has an infection with a piperacillin/tazobactam resistant organism (i.e. P. aeruginosa with MIC =16 mg/L, other organism with MIC = 8mg/L) or organisms with inherent resistance (e.g. Stenotrophomonas) 3. Subject is immunocompromised (neutropenia, HIV/AIDS) 4. Subject is unlikely to survive longer the 48 hours 5. Subject is pregnant or breast-feeding or plans to become pregnant during the course of the study 6. Subject is enrolled in another Clinical Trial of an Investigational Medical Product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary object of this study is to investigate changes over time in blood and lung concentrations of piperacillin and tazobactam in critically ill patients. ;Secondary Objective: 1. To investigate how much and how quickly piperacillin irreversibly binds to protein in the blood. 2. To investigate how the permaebilty of the lung to fluid affects the concentration of antibiotic in the lung. 3. To investigate if different types of infectious organisms affect the variability in drug levels seen in critically ill patients. 4. To investigate if the amount of inflammation affects the variability in drug levels seen in critically ill patients. 5. To collect the bacteria and fungus from this very specific group of patients for future laboratory studies. 6. To see how antibiotics affect the bacteria and fungus growing on the endotracheal tube of critically ill patients.;Primary end point(s): The primary outcome measure is blood and lung concentrations of piperacillin and tazobactam.;Timepoint(s) of evaluation of this end point: Five days of piperacillin/Tazobactam | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. All cause mortality 28 days after commencing antibiotics 2. Microbiological clearance of infection 3. Number of ventilator-free days;Timepoint(s) of evaluation of this end point: Mortality and ventilator free days will have an endpoint of 28 days. Microbiological clearance of infection has an endpoint of 5 days. | — |
Countries
United Kingdom
Contacts
Public ContactTim Felton
The University of Manchester
Outcome results
None listed