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

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ClinicalTrials.gov Identifier: NCT01897831
Recruitment Status : Unknown
Verified September 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was:  Enrolling by invitation
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd

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 under the widely used in clinical conditions.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Urinary Tract Infections Drug: xin te mie 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 by irreversible competitive inhibition of β-lactamase. The antimicrobial effect of cefotaxime 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.

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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: A Open Multi-center Clinical Study on Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Study Start Date : August 2011
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: xin te mie
1.5-3.0g,iv,bid or tid for 7-14 days
Drug: xin te mie
durg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days
Other Names:
  • te mie jun
  • xin ke jun




Primary Outcome Measures :
  1. overall effect [ Time Frame: two year ]

    end of treatment of bacteriological efficacy(bacterial clearance)

    The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs



Secondary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: two year ]
    the incidence(%)of allergies, skin rashes, shock,death, etc.



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Ages Eligible for Study:   18 Years and older   (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.

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): NCT01897831


Sponsors and Collaborators
Xiangbei Welman Pharmaceutical Co., Ltd
Investigators
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Study Director: changqing cq li, doctor Chongqing Red Cross Hospital

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Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01897831     History of Changes
Other Study ID Numbers: 2002 H L 0153
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: September 2012

Keywords provided by Xiangbei Welman Pharmaceutical Co., Ltd:
Piperacillin Sodium and sulbactam sodium
Phase IV clinical studies
Respiratory and urinary tract infections

Additional relevant MeSH terms:
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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