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Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection (PIP-SBT)

This study is currently recruiting participants.
Verified December 2012 by Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01760109
First received: December 19, 2012
Last updated: December 30, 2012
Last verified: December 2012
History of Changes
  Purpose

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin 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: Piperacillin Sodium and Sulbactam Sodium
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study on Piperacillin 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: 2000
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Piperacillin Sodium and Sulbactam Sodium

Drug:xintemie 1.5-3.0g,iv,bid 7-14 days

serious infections 6.0-12.0g,iv,tid for 7-14 days

 Drug: Piperacillin Sodium and Sulbactam Sodium
1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
Other Names:
  • xin te mie
  • te mie jun
  • xin ke jun

Detailed Description:

Piperacillin 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 Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin 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. Age>18 years old, Gender: both
  3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
  4. patients were volunteers and signed informed consent form;
  5. patients did not participate in other clinical trials.

Exclusion Criteria:

  1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
  2. Pregnant and Lactating women
  3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
  4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760109

Contacts
Contact: Ting Wang, doctor 020-38868707 wmrd@welman.com.cn
Contact: Rong Lin, bachelor 020-38868707 linrong@welman.com.cn

Locations
China
Chongqing Red Cross hospital Recruiting
Chongqing, China, 400020
Contact: Changqing Li, doctor     (023)88519201        
Sub-Investigator: Changqing Li, doctor            
Sponsors and Collaborators
Xiangbei Welman Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Changqing Li, doctor Chongqing Red Cross Hospital
  More Information

No publications provided

Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01760109     History of Changes
Other Study ID Numbers: 2002HL0153
Study First Received: December 19, 2012
Last Updated: December 30, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013