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Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

Primary Purpose

Nosocomial Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
C Group
E Group
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nosocomial Pneumonia focused on measuring Piperacillin/tazobactam, MIC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TianjinCIHRecruiting
  • TianjinCIHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

C Group

E Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reducing antibiotic resistance
To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia.

Full Information

First Posted
August 30, 2012
Last Updated
February 14, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01796717
Brief Title
Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia. To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or intermittent infusion in patients with nosocomial pneumonia.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Pneumonia
Keywords
Piperacillin/tazobactam, MIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C Group
Arm Type
Active Comparator
Arm Description
Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes
Arm Title
E Group
Arm Type
Experimental
Arm Description
Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours
Intervention Type
Drug
Intervention Name(s)
C Group
Other Intervention Name(s)
nosocomial pneumonia, MIC
Intervention Description
Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes
Intervention Type
Drug
Intervention Name(s)
E Group
Other Intervention Name(s)
nosocomial pneumonia, MIC
Intervention Description
Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours
Primary Outcome Measure Information:
Title
Extension of the Piperacillin / tazobactam infusion time effect evaluation
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Reducing antibiotic resistance
Description
To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Donghao, chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Donghao, Chief
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
TianjinCIH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Donghao, Chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yang Yang, resident
First Name & Middle Initial & Last Name & Degree
lv yang, resident
Facility Name
TianjinCIH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Donghao, Chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
20018492
Citation
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.
Results Reference
background
PubMed Identifier
20047820
Citation
Wang H, Chen M, Ni Y, Liu Y, Sun H, Yu Y, Yu X, Mei Y, Liu M, Sun Z, Chu Y, Hu Z, Huang X. Antimicrobial resistance among clinical isolates from the Chinese Meropenem Surveillance Study (CMSS), 2003-2008. Int J Antimicrob Agents. 2010 Mar;35(3):227-34. doi: 10.1016/j.ijantimicag.2009.11.010. Epub 2010 Jan 4.
Results Reference
background
PubMed Identifier
19150225
Citation
Lorente L, Jimenez A, Martin MM, Iribarren JL, Jimenez JJ, Mora ML. Clinical cure of ventilator-associated pneumonia treated with piperacillin/tazobactam administered by continuous or intermittent infusion. Int J Antimicrob Agents. 2009 May;33(5):464-8. doi: 10.1016/j.ijantimicag.2008.10.025. Epub 2009 Jan 15.
Results Reference
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Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

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