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

This study is currently recruiting participants.
Verified April 2012 by Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01601093
First received: April 27, 2012
Last updated: May 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Tract Infections
Urinary Tract Infections
 Drug: Ceftazidime and Sulbactam Sodium (High dose)
Drug: Ceftazidime and Sulbactam Sodium (Low dose)
Drug: Cefoperazone and Sulbactam Sodium (CFP/SUB)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xiangbei Welman Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • The rate of bacterial clearance [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    the incidence(%)of allergies, skin rashes, shock,death, etc.


Estimated Enrollment: 288
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose
Ceftazidime 3g
 Drug: Ceftazidime and Sulbactam Sodium (High dose)
Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
Other Name: high dose group
Experimental: Low dose
Ceftazidime 2g
 Drug: Ceftazidime and Sulbactam Sodium (Low dose)
Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
Other Name: low dose group
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 Name: CFP/SUB(2:1)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601093

Contacts
Contact: ting wt wang, doctor 020-38868707 wmrd@welman.com.cn
Contact: yaowen yw lu, master 020-38868707 gap@welman.com.cn

Locations
China, Jiangsu
the First Affiliated Hospital With Medical University Recruiting
Nanjing, Jiangsu, China
Contact: hong wh wang, doctor     025-83714511 ext 6360        
Sub-Investigator: mao hm huang, doctor            
Sponsors and Collaborators
Xiangbei Welman Pharmaceutical Co., Ltd
Investigators
Principal Investigator: hong wh wang, doctor The first affliated hospital with Nanjing Medical University
  More Information

No publications provided

Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01601093     History of Changes
Other Study ID Numbers: 2008L03354
Study First Received: April 27, 2012
Last Updated: May 16, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xiangbei Welman Pharmaceutical Co., Ltd:
Respiratory and urinary tract infections
Ceftazidime and Sulbactam Sodium for Injection (2:1)
Phase Ⅱ

Additional relevant MeSH terms:
Respiratory Tract Infections
Urinary Tract Infections
Infection
Respiratory Tract Diseases
Urologic Diseases
Cefoperazone
Ceftazidime
Sulbactam
Sulperazone
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013