Status:
UNKNOWN
Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Nosocomial Pneumonia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
1. To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia. 2. To describe...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 70 years old.
- Inpatients with nosocomial pneumonia or bacteremia.
- i. Diagnosis of nosocomial pneumonia
- Chest radiographic infiltrate that is new or progressive.
- 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.
- Patients are infected by piperacillin-tazobactam susceptible pathogen with MIC=4, 8 or 16mg/L.
Exclusion
- The patients who received systematic antibacterial treatment more than 48 hours before enrollment and have clinical response.
- 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).
- Documented infection caused by pathogens beyond the antibacterial spectrum of piperacillin/tazobactam.
- 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.
- History of allergy to penicillins.
- Pregnancy or breast-feeding women.
- Any conditions investigator considered might increase the risk of patients or interfere study results.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01796717
Start Date
March 1 2012
End Date
December 1 2016
Last Update
February 17 2016
Active Locations (2)
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1
TianjinCIH
Tianjin, Tianjin Municipality, China, 300060
2
TianjinCIH
Tianjin, Tianjin Municipality, China, 300060