Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

Urinary Tract Infections Clinical Trial

— CAZ-SBT  

Official title:

Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01601093
• Other study ID #: 2008L03354
• Status: Suspended
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2019
• Source: Xiangbei Welman Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 288
• Est. completion date: December 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ,ß-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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Urinary Tract Infections

Intervention

Drug:
• High dose
Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
• Low dose
Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
• Cefoperazone and Sulbactam Sodium (CFP/SUB)
Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Locations

Country	Name	City	State
China	the First Affiliated Hospital With Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xiangbei Welman Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with Adverse Events	the incidence(%)of allergies, skin rashes, shock,death, etc.	two years