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

Xiangbei Welman Pharmaceutical

Status and phase: Suspended; Phase 2

Conditions: Urinary Tract Infections; Respiratory Tract Infections

Treatments: Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB); Drug: Low dose; Drug: High dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01601093

2008L03354

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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288 participants in 3 patient groups

High dose

Experimental group

Description:

Ceftazidime 3g

Treatment:

Drug: High dose

Low dose

Experimental group

Description:

Ceftazidime 2g

Treatment:

Drug: Low dose

CFP/SUB

Active Comparator group

Description:

Cefoperazone and sulbactam sodium for injection(2:1)

Treatment:

Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)