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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

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:

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

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

NCT ID

NCT01796717

First Posted

August 30, 2012

Last Updated

February 14, 2016

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Pfizer

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

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

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

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

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

background

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Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

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