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

Primary Purpose

Respiratory Tract Infections, Urinary Tract Infections

Status

Suspended

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

High dose

Low dose

Cefoperazone and Sulbactam Sodium (CFP/SUB)

About this trial

This is an interventional treatment trial for Respiratory Tract Infections focused on measuring Respiratory and urinary tract infections, Ceftazidime and Sulbactam Sodium for Injection (2:1), Phase Ⅱ

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

the First Affiliated Hospital With Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

High dose

Low dose

CFP/SUB

Arm Description

Ceftazidime 3g

Ceftazidime 2g

Cefoperazone and sulbactam sodium for injection(2:1)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with Adverse Events

the incidence(%)of allergies, skin rashes, shock,death, etc.

Full Information

NCT ID

NCT01601093

First Posted

April 27, 2012

Last Updated

July 2, 2019

Sponsor

Xiangbei Welman Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01601093

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Suspended

Why Stopped

other project got priority

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 15, 2022 (Anticipated)

Study Completion Date

December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiangbei Welman Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infections, Urinary Tract Infections

Keywords

Respiratory and urinary tract infections, Ceftazidime and Sulbactam Sodium for Injection (2:1), Phase Ⅱ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High dose

Arm Type

Experimental

Arm Description

Ceftazidime 3g

Arm Title

Low dose

Arm Type

Experimental

Arm Description

Ceftazidime 2g

Arm Title

CFP/SUB

Arm Type

Active Comparator

Arm Description

Cefoperazone and sulbactam sodium for injection(2:1)

Intervention Type

Drug

Intervention Name(s)

High dose

Other Intervention Name(s)

high dose group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Low dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cefoperazone and Sulbactam Sodium (CFP/SUB)

Other Intervention Name(s)

CFP/SUB(2:1)

Intervention Description

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

Primary Outcome Measure Information:

Title

The rate of bacterial clearance

Description

end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

Time Frame

two years

Secondary Outcome Measure Information:

Title

Number of participants with Adverse Events

Description

the incidence(%)of allergies, skin rashes, shock,death, etc.

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hong wh wang, doctor

Organizational Affiliation

The first affliated hospital with Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the First Affiliated Hospital With Medical University

City

Nanjing

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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