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

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

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.

Study Overview

• Status: Suspended
• Conditions: Respiratory Tract Infections; Urinary Tract Infections
• Intervention / Treatment: Drug: High dose; Drug: Low dose; Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • the First Affiliated Hospital With Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose; Ceftazidime 3g	Drug: High dose; Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.; Other Names: high dose group
Experimental: Low dose; Ceftazidime 2g	Drug: Low dose; Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
Active Comparator: CFP/SUB; Cefoperazone and sulbactam sodium for injection(2:1)	Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB); Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.; Other Names: CFP/SUB(2:1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events	the incidence(%)of allergies, skin rashes, shock,death, etc.	two years

Collaborators and Investigators

• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: hong wh wang, doctor, The First Affliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Respiratory and urinary tract infections; Ceftazidime and Sulbactam Sodium for Injection (2:1); Phase Ⅱ
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Sulbactam; Cefoperazone; Sulperazone
• Other Study ID Numbers: 2008L03354