Know Cancer

forgot password

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

Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Nosocomial Pneumonia

Thank you

Trial Information

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.

Inclusion Criteria:

1. Male or female, aged 18 to 70 years old.

2. Inpatients with nosocomial pneumonia or bacteremia.

i. Diagnosis of nosocomial pneumonia

1. Chest radiographic infiltrate that is new or progressive.

2. At least two or more of the following clinical findings suggesting infection.

- New onset of fever, oral temperature T>38.3℃ or T<36℃

- Purulent sputum

- WBC > 12×10^9/L or <4×10^9/L, or band form >10%

- PaO2/FIO2<240mmHg

ii. Diagnosis of bacteremia: Positive blood culture and the isolated bacterial strain
are considered to be infection cause.

3. Patients are infected by piperacillin-tazobactam susceptible pathogen with MIC=4, 8
or 16mg/L.

Exclusion Criteria:

1. The patients who received systematic antibacterial treatment more than 48 hours
before enrollment and have clinical response.

2. Severe pyemia with hypotension or/and evidences of failure of organic function
(shock: systolic pressure < 90mmHg or diastolic pressure < 60mmHg, requiring more
than 4 hours of administration of vasopressor(s);renal impairment: urine volume < 20
ml∕h or < 80 ml∕4h after excluded any other potentials, acute renal failure need
dialysis, CLcr<40 mL/min).

3. Documented infection caused by pathogens beyond the antibacterial spectrum of

4. Previously diagnosed condition which tend to mimic or complicate the course and
evaluation of the infectious process, e.g. bronchial obstruction, obstructive
pneumonia, activate pulmonary malignancy, pulmonary abscess, empyema and active
tuberculosis, which might interfere the course of the infectious disease and
evaluation of the disease.

5. History of allergy to penicillins.

6. Pregnancy or breast-feeding women.

7. Any conditions investigator considered might increase the risk of patients or
interfere study results.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Extension of the Piperacillin / tazobactam infusion time effect evaluation

Outcome Description:

To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia.

Outcome Time Frame:

2 weeks

Safety Issue:


Principal Investigator

Wang Donghao, Chief

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital


China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

August 2013

Related Keywords:

  • Nosocomial Pneumonia
  • Piperacillin/tazobactam
  • MIC
  • Pneumonia