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

Completed

• Conditions: Respiratory Tract Infections; Urinary Tract Infections
• Interventions: Drug: xinzhijun

• Registration Number: NCT01426191
• Lead Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2015-04
• Study Completion: 2016-12
• Results First Submitted: 2019-07-02
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Results First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2032

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
xinzhijun	xinzhijun	1.5-3.0g,iv,bid or tid for 5-12 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	day0-day22-28	the incidence(%)of allergies, skin rashes, shock,death, etc.

Secondary Outcome Measures

Name	Time	Method
Clinical Effect	at weeks 4,day22-28	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).