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.
Drug: High dose
Drug: Low dose
Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)
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Locations near you
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Full eligibility criteria for NCT01601093
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01601093
the First Affiliated Hospital With Medical University
Nanjing, Jiangsu, China
View full eligibility
Tris trial is registered with FDA with number: NCT01601093. The sponsor of the trial is Xiangbei Welman Pharmaceutical Co., Ltd and it is looking for 288 volunteers for the current phase.
Official trial title: Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
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