Trial | NCT01760109  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2000
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.
Study Started
Jul 31
2011
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jul 08
2019

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

Piperacillin Sodium and Sulbactam Sodium Experimental

Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days

Criteria 

Inclusion Criteria:

patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
Age>18 years old, Gender: both
Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
patients were volunteers and signed informed consent form;
patients did not participate in other clinical trials.

Exclusion Criteria:

Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
Pregnant and Lactating women
Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
No Results Posted