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

Urinary Tract Infections Clinical Trial

— SWSB  

Official title:

A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426191
• Other study ID #: 20090095
• Status: Completed
• Start date: August 2011
• Est. completion date: December 2016

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2032
• Est. completion date: December 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

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	Number of Participants With Adverse Events	the incidence(%)of allergies, skin rashes, shock,death, etc.	day0-day22-28
Secondary	Clinical Effect	outcome:1.clinical cure 2. clinical failure population included patients who received the study drug, complied with the study protocol, did not have a missing or indeterminate clinical outcome response at the test-of-cure (TOC) visit, and had no confounding factors that interfered with the assessment of clinical outcome (e.g., use of nonstudy systemic antibiotic therapy on or after the first dose of the study drug for reasons other than treatment failure).	at weeks 4,day22-28