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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Xiangbei Welman Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT01426191

First received: August 23, 2011

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2011

Last Updated Date

September 10, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

overall effect [ Time Frame: two year ] [ Designated as safety issue: No ]

end of treatment of bacteriological efficacy(bacterial clearance)

The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs

Original Primary Outcome Measures ^ICMJE

overall effect [ Time Frame: two year ] [ Designated as safety issue: No ]

end of treatment of bacteriological efficacy(bactercial clearance)

The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs

Change History

Complete list of historical versions of study NCT01426191 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of participants with Adverse Events [ Time Frame: two year ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

hospitalized patients or outpatients

Condition ^ICMJE

Respiratory Tract Infections
Urinary Tract Infections

Intervention ^ICMJE

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

Other Names:

Experimental
shumate

Study Group/Cohort (s)

xinzhijun

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

Intervention: Drug: xinzhijun

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

November 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01426191

Other Study ID Numbers ^ICMJE

20090095

Has Data Monitoring Committee

Yes

Responsible Party

Xiangbei Welman Pharmaceutical Co., Ltd

Study Sponsor ^ICMJE

Xiangbei Welman Pharmaceutical Co., Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	lanjuan lj li, docter	Zhejiang University
Study Director:	changqing cq li, doctor	Chongqing Red Cross Hospital

Information Provided By

Xiangbei Welman Pharmaceutical Co., Ltd

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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