ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

December 19, 2012
January 3, 2013
January 3, 2013
July 2011
November 2013   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Number of participants with Adverse Events [ Time Frame: two years ]
the incidence(%)of allergies, skin rashes, shock,death, etc.
Same as current
Not Provided
Not Provided
 
Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Phase IV Study on Piperacillin 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 Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Respiratory Tract Infections
  • Urinary Tract Infections
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
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

Intervention: Drug: Piperacillin Sodium and Sulbactam Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
2000
Same as current
December 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01760109
2002HL0153
Yes
Not Provided
Not Provided
Xiangbei Welman Pharmaceutical Co., Ltd
Xiangbei Welman Pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Changqing Li, doctor Chongqing Red Cross Hospital
Xiangbei Welman Pharmaceutical Co., Ltd
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP