Clinical trial NCT01601093: Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Official title: Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Respiratory Tract Infections
Urinary Tract Infections
Keywords: Respiratory and urinary tract infections
Ceftazidime and Sulbactam Sodium for Injection (2:1)
Phase Ⅱ
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Hospital patients or good compliance clinic patients, who were more than 18 years old and less than 70 years old, Gender: both.
3. Patients who do not take other antibiotic medications before screening period.
4. 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)
5. Pathogenic bacteria was resistant to ceftazidime and sensitive to both of test drugs and contrast drugs.
6. Women of childbearing was to be negative pregnancy test and agree to take contraceptive measures during the trial.
7. Patients were volunteers and signed informed consent from.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pathogenic bacteria was sensitive to ceftazidime or resistant to ceftazidime,test drugs and control drugs.
3. Patients who need to take other antibiotic medicine because of concurrent infection.
4. Patients who took medicine which affected efficacy evaluations and safety evaluations such as aspirin, indomethacin, phenylbutazone, sulfanilamide, disulfiram and probenecid in the trial.
5. Patients who took risks of severe drug interactions because of drug combination.
6. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
7. Pregnant and Lactating women
8. Drug addicts and alcoholics.
9. Patients who once was selected in this trial.
10. Patients who participated in other clinical trials in the past three months.

Primary outcomes:
measure: The rate of bacterial clearance
timeFrame: two years
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: two years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital With Medical University
state: Jiangsu
Study officials:
affiliation: The first affliated hospital with Nanjing Medical University
name: hong wh wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: