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

Urinary Tract Infections Clinical Trial

— PIP-SBT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01897831
• Other study ID #: 2002 H L 0153
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 3, 2013
• Last updated: July 9, 2013
• Start date: August 2011
• Est. completion date: November 2015

Study information

• Verified date: September 2012
• Source: Xiangbei Welman Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• 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 under the widely used in clinical conditions.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangbei Welman Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall effect	end of treatment of bacteriological efficacy(bacterial clearance); The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs	two year	No
Secondary	Number of participants with Adverse Events	the incidence(%)of allergies, skin rashes, shock,death, etc.	two year	No