Optimizing Dosing Regimen of Piperacillin/Tazobactam, Prolonged Infusion vs. Regular Infusion, Every 6 Hours, for Nosocomial Pneumonia in ICU Caused by Susceptible Pathogens With Higher MIC
Enrolled patients will be randomized into therapeutic or controlled group. Controlled group
will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes.
Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4
hours. The duration is 7-14 days.
Two sets of blood cultures (for aerobic and anaerobic culture) were obtained before the
study and post-treatment period if first blood culture is positive. Cultures from the lower
respiratory tract infection were obtained before (within 48 h) the study and on the last day
of therapy. The lower respiratory tract specimens obtained either by endotracheal
aspiration, bronchoalveolar lavage (BAL), a protected brush procedure (PBP) or as sputum
were required to show > 25 polymorphonuclear cells and < 10 squamous epithelial cells per
field (at 100× magnification).
The plasma concentration of piperacillin and tazobactam will be determined by LC/MS/MS
method. The QC samples will also be analyzed simultaneously with each run for the method
stability testing, according to the laboratory standard procedure.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Extension of the Piperacillin / tazobactam infusion time effect evaluation
To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia.
Wang Donghao, Chief
Tianjin Medical University Cancer Institute and Hospital
China: Food and Drug Administration