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

NCT ID: NCT01426191

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2032 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2016-12-31

Brief Summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime 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.

Detailed Description

Cefotaxime is a third-generation cephalosporins.Cefotaxime 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 cefotaxime in the treatment-resistant pathogen infections.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

xinzhijun

1.5-3.0g,iv,bid or tid for 5-12 days

xinzhijun

Intervention Type: DRUG

durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)

1.5-3.0g,iv,bid or tid for 5-12 days;

Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days

Interventions

xinzhijun

durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)

1.5-3.0g,iv,bid or tid for 5-12 days;

Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days

Intervention Type: DRUG

Other Intervention Names

Experimental; shumate

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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangbei Welman Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lanjuan lj li, docter

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

changqing cq li, doctor

Role: STUDY_DIRECTOR

Chongqing Red Cross Hospital

Other Identifiers

20090095

Identifier Type: -

Identifier Source: org_study_id