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

NCT ID: NCT01760109

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-06-30

Brief 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.

Detailed 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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Piperacillin Sodium and Sulbactam Sodium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

xin te mie; te mie jun; xin ke jun

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changqing Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Chongqing Red Cross Hospital

Locations

Chongqing Red Cross hospital

Chongqing, , China

Countries

China

Other Identifiers

2002HL0153

Identifier Type: -

Identifier Source: org_study_id