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

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.

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Key information

Conditions

Respiratory Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Respiratory Tract Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
Age>18 years old, Gender: both
Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
patients were volunteers and signed informed consent form;
patients did not participate in other clinical trials.

Exclusion criteria

Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
Pregnant and Lactating women
Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Treatment and study plan

xinzhijun

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

Other names: Experimental, shumate

Primary outcomes

Number of Participants With Adverse Events

Time frame: day0-day22-28

the incidence(%)of allergies, skin rashes, shock,death, etc.

Secondary outcomes

Clinical Effect

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Xiangbei Welman Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: SWSB

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: Aug 31, 2011
Registry last updated: Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed