Study on Ceftazidime 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 Ceftazidime 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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Ceftazidime is a third-generation cephalosporins. Ceftazidime 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 ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.

Official Title
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Phase Ⅱ Study on Ceftazidime 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: High dose
* Drug: Low dose
* Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)


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. Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both. Patients who do not take other antibiotic medications before screening period. Patients who have no severe liver, kidney and hematopoietic system of diseases (Both AST and ALT are less than 1.5 times of the upper limit of normal and Cr is in normal range) Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs. Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial. Patients were volunteers and signed informed consent from. Exclusion Criteria: Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs. Patients who need to take other antibiotic medicine because of concurrent infection. Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial. Patients who took risks of severe drug interactions because of drug combination. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance. Pregnant and Lactating women Drug addicts and alcoholics. Patients who once was selected in this trial. Patients who participated in other clinical trials in the past three months.

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br>Ceftazidime 3g | Drug: High dose<br>* Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.<br>* Other names: high dose group;|
| Experimental: Low dose<br>Ceftazidime 2g | Drug: Low dose<br>* Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.<br>|
| Active Comparator: CFP/SUB<br>Cefoperazone and sulbactam sodium for injection(2:1) | Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)<br>* Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.<br>* Other names: CFP/SUB(2:1);|

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, Ceftazidime and Sulbactam Sodium for Injection (2:1), Phase Ⅱ