Back to resultsPiperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (PIP-SBT)
Primary Purpose
Respiratory Tract Infections, Urinary Tract Infections
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
xin te mie
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Infections focused on measuring Piperacillin Sodium and sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
xin te mie
Arm Description
1.5-3.0g,iv,bid or tid for 7-14 days
Outcomes
Primary Outcome Measures
overall effect
end of treatment of bacteriological efficacy(bacterial clearance)
The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs
Secondary Outcome Measures
Number of participants with Adverse Events
the incidence(%)of allergies, skin rashes, shock,death, etc.
Full Information
NCT ID
NCT01897831
First Posted
June 3, 2013
Last Updated
July 9, 2013
Sponsor
Xiangbei Welman Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01897831
Brief Title
Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Acronym
PIP-SBT
Official Title
A Open Multi-center Clinical Study on Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
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 under the widely used in clinical conditions.
Detailed Description
Piperacillin sodium and sulbactam sodium for injection (2:1) plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase. The antimicrobial effect of cefotaxime 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
Piperacillin Sodium and sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections
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 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
xin te mie
Arm Type
Experimental
Arm Description
1.5-3.0g,iv,bid or tid for 7-14 days
Intervention Type
Drug
Intervention Name(s)
xin te mie
Other Intervention Name(s)
te mie jun, xin ke jun
Intervention Description
durg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days
Primary Outcome Measure Information:
Title
overall effect
Description
end of treatment of bacteriological efficacy(bacterial clearance)
The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs
Time Frame
two year
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
the incidence(%)of allergies, skin rashes, shock,death, etc.
Time Frame
two year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 cq li, doctor
Organizational Affiliation
Chongqing Red Cross Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
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