Skip to main content
OpenTrials
Completed

NCT Number: NCT01760109

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Respiratory Tract Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chongqing Red Cross hospital

Chongqing, 400020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Piperacillin Sodium and Sulbactam Sodium

Drug

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

Primary outcomes

  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 outcomes

  1. Number of participants with Adverse Events

    Time frame: two years

    the incidence(%)of allergies, skin rashes, shock,death, etc.

Sponsors and collaborators

Lead sponsor

Xiangbei Welman Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

Acronym: PIP-SBT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2013
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.