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Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection (PIP-SBT)

Primary Purpose

Respiratory Tract Infections, Urinary Tract Infections

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Piperacillin Sodium and Sulbactam Sodium
Sponsored by
Xiangbei Welman Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections focused on measuring Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV

Eligibility Criteria

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

Inclusion Criteria:

  1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
  2. Age>18 years old, Gender: both
  3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
  4. patients were volunteers and signed informed consent form;
  5. patients did not participate in other clinical trials.

Exclusion Criteria:

  1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
  2. Pregnant and Lactating women
  3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
  4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Sites / Locations

  • Chongqing Red Cross hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Piperacillin Sodium and Sulbactam Sodium

Arm Description

Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Outcomes

Primary Outcome Measures

The rate of bacterial clearance
end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

Secondary Outcome Measures

Number of participants with Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.

Full Information

First Posted
December 19, 2012
Last Updated
July 3, 2019
Sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01760109
Brief Title
Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Acronym
PIP-SBT
Official Title
Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangbei Welman Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
Detailed Description
Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Urinary Tract Infections
Keywords
Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piperacillin Sodium and Sulbactam Sodium
Arm Type
Experimental
Arm Description
Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
Intervention Type
Drug
Intervention Name(s)
Piperacillin Sodium and Sulbactam Sodium
Other Intervention Name(s)
xin te mie, te mie jun, xin ke jun
Intervention Description
1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
Primary Outcome Measure Information:
Title
The rate of bacterial clearance
Description
end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs
Time Frame
two years
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
the incidence(%)of allergies, skin rashes, shock,death, etc.
Time Frame
two years

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: patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy. Age>18 years old, Gender: both Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial; patients were volunteers and signed informed consent form; patients did not participate in other clinical trials. Exclusion Criteria: Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor Pregnant and Lactating women Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changqing Li, doctor
Organizational Affiliation
Chongqing Red Cross Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Red Cross hospital
City
Chongqing
ZIP/Postal Code
400020
Country
China

12. IPD Sharing Statement

Learn more about this trial

Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

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