PROPEL

• Research type

  Research Study

• Full title

  Plasma and intrapulmonary population pharmacokinetics of piperacillin/tazobactam in critically ill patients

• IRAS ID

  69881

• Contact name

  Tim Felton

• Sponsor organisation

  University Hospital of South Manchester

• Eudract number

  2011-004470-28

• Research summary

  Ventilator associated pneumonia (VAP) is a frequently fatal disease affecting patients in intensive care. These patients are commonly treated with piperacillin/tazobactam (pip/taz), a broad spectrum antibiotic extensively used in the NHS. This study aims to investigate changes over time in blood and lung concentrations of piperacillin and tazobactam in critically ill patients. Low concentrations of pip/taz are associated with failure of the antibiotic to treat infection and emergence of antibiotic resistance. High concentrations are associated with increased risk of side effects. The data will be used to build a computer model that will describe the amount of variation between critically ill patients given the same amount of drug. Patients are only eligible if the medical intensive care team commence pip/taz as part of routine care. Delay in starting antibiotics is associated with adverse outcomes. Consent from patients will be attempted where appropriate but in most cases consent will be sought from patients?? representatives. Patients will be enrolled in the study and only initial samples will be collected prior to consent being gained. Consent must be gained within 48 hours of first dose of antibiotic. Six/Seven blood samples will be collected relative to the first and (approx) seventh dose of pip/taz. The initial samples are collected prior to dosing. The blood samples will be at pre-described time intervals post dose administration. A total of four samples will be collected from the lungs. Each sample is collected by washing a small volume oflud into and, immediately, out of the lungs. Two samples will be used to measure drug levels in the lung the remaining samples will be used for microbiological culture. Additional blood samples will be used to measure kidney function, which is important for clearance of pip/taz, and for markers of inflammation.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0680

• Date of REC Opinion

  18 Oct 2011

• REC opinion

  Favourable Opinion