Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract 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 Cefotaxime 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
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Cefotaxime is a third-generation cephalosporins.Cefotaxime 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 cefotaxime in the treatment-resistant pathogen infections.

Official Title
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A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection

Conditions
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Respiratory Tract Infections, Urinary Tract Infections

Intervention / Treatment
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* Drug: xinzhijun


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

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| xinzhijun<br>1.5-3.0g,iv,bid or tid for 5-12 days | Drug: xinzhijun<br>* durg:Cefotaxime sodium and sulbactam sodium for injection(2:1) 1.5-3.0g,iv,bid or tid for 5-12 days; Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days<br>* Other names: shumate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | the incidence(%)of allergies, skin rashes, shock,death, etc. | day0-day22-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Effect | outcome:1.clinical cure 2. clinical failure population included patients who received the study drug, complied with the study protocol, did not have a missing or indeterminate clinical outcome response at the test-of-cure (TOC) visit, and had no confounding factors that interfered with the assessment of clinical outcome (e.g., use of nonstudy systemic antibiotic therapy on or after the first dose of the study drug for reasons other than treatment failure). | at weeks 4,day22-28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cefotaxime sulbactam sodium, Phase IV clinical studies, Respiratory and urinary tract infections