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

NCT ID: NCT01601093

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2022-12-15

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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High dose

Ceftazidime 3g

Group Type: EXPERIMENTAL

High dose

Intervention Type: DRUG

Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.

Low dose

Ceftazidime 2g

Group Type: EXPERIMENTAL

Low dose

Intervention Type: DRUG

Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

CFP/SUB

Cefoperazone and sulbactam sodium for injection(2:1)

Group Type: ACTIVE_COMPARATOR

Cefoperazone and Sulbactam Sodium (CFP/SUB)

Intervention Type: DRUG

Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Interventions

High dose

Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.

Intervention Type: DRUG

Low dose

Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Intervention Type: DRUG

Cefoperazone and Sulbactam Sodium (CFP/SUB)

Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Intervention Type: DRUG

Other Intervention Names

high dose group; CFP/SUB(2:1)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hong wh wang, doctor

Role: PRINCIPAL_INVESTIGATOR

The first affliated hospital with Nanjing Medical University

Locations

the First Affiliated Hospital With Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2008L03354

Identifier Type: -

Identifier Source: org_study_id