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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

Conditions
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Respiratory Tract Infections, Urinary Tract Infections

Intervention / Treatment
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* Drug: Piperacillin Sodium and Sulbactam Sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piperacillin Sodium and Sulbactam Sodium<br>Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days | Drug: Piperacillin Sodium and Sulbactam Sodium<br>* 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days<br>* Other names: xin ke jun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events | the incidence(%)of allergies, skin rashes, shock,death, etc. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV