Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT01796717
• Date of registration: 30/08/2012
• Prospective Registration: No
• Primary sponsor: Tianjin Medical University Cancer Institute and Hospital
• Public title: Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia
• Scientific title: 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
• Date of first enrolment: March 2012
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT01796717
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Wang Donghao, Chief
• Affiliation: Tianjin Medical University Cancer Institute and Hospital

• Name: Wang Donghao, chief

Key inclusion & exclusion criteria

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
piperacillin/tazobactam.

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Nosocomial Pneumonia

Intervention(s)

Drug: C Group

Drug: E Group

Primary Outcome(s)

Extension of the Piperacillin / tazobactam infusion time effect evaluation [Time Frame: 2 weeks]

Secondary Outcome(s)

Reducing antibiotic resistance [Time Frame: 2 weeks]

Secondary ID(s)

CIH-WDH-201205001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer