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

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ClinicalTrials.gov Identifier: NCT01760109
Recruitment Status : Unknown
Verified December 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Tract Infections Urinary Tract Infections Drug: Piperacillin Sodium and Sulbactam Sodium Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The rate of bacterial clearance [ Time Frame: two years ]
    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 :
  1. Number of participants with Adverse Events [ Time Frame: two years ]
    the incidence(%)of allergies, skin rashes, shock,death, etc.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01760109     History of Changes
Other Study ID Numbers: 2002HL0153
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012

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:
Infection
Communicable Diseases
Urinary Tract Infections
Respiratory Tract Infections
Urologic Diseases
Respiratory Tract Diseases
Piperacillin
 Sulbactam
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action