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

Urinary Tract Infections Clinical Trial

— PIP-SBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760109
• Other study ID #: 2002HL0153
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: July 2019
• Source: Xiangbei Welman Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ,ß-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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
China	Chongqing Red Cross hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xiangbei Welman Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of bacterial clearance	end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs	two years
Secondary	Number of participants with Adverse Events	the incidence(%)of allergies, skin rashes, shock,death, etc.	two years