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Nosocomial Pneumonia | Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

Nosocomial Pneumonia research study

What is the primary objective of this study?

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 the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia. 3. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or intermittent infusion in patients with nosocomial pneumonia.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nosocomial Pneumonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:C GroupControlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes

Drug:E GroupTherapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

C GroupControlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes

E GroupTherapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours

Study Status

Unknown status

Start Date: March 2012

Completed Date: December 2016

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Extension of the Piperacillin / tazobactam infusion time effect evaluation

Secondary Outcome: Reducing antibiotic resistance

Study sponsors, principal investigator, and references

Principal Investigator: Wang Donghao, Chief

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01796717

Roberts JA, Kirkpatrick CM, Roberts MS, Dalley AJ, Lipman J. First-dose and steady-state population pharmacokinetics and pharmacodynamics of piperacillin by continuous or intermittent dosing in critically ill patients with sepsis. Int J Antimicrob Agents. 2010 Feb;35(2):156-63. doi: 10.1016/j.ijantimicag.2009.10.008. Epub 2009 Dec 16.

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