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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426191
Recruitment Status : Unknown
Verified September 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was:  Enrolling by invitation
First Posted : August 31, 2011
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Urinary Tract Infections Drug: xinzhijun Phase 4

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 : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1.5-3.0g,iv,bid or tid for 5-12 days
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

Primary Outcome Measures :
  1. overall effect [ Time Frame: two year ]

    end of treatment of bacteriological efficacy(bacterial clearance)

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

Secondary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: two year ]
    the incidence(%)of allergies, skin rashes, shock,death, etc.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitalized patients or outpatients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426191

Sponsors and Collaborators
Xiangbei Welman Pharmaceutical Co., Ltd
Principal Investigator: lanjuan lj li, docter Zhejiang University
Study Director: changqing cq li, doctor Chongqing Red Cross Hospital

Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd Identifier: NCT01426191     History of Changes
Other Study ID Numbers: 20090095
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Xiangbei Welman Pharmaceutical Co., Ltd:
Cefotaxime sulbactam sodium
Phase IV clinical studies
Respiratory and urinary tract infections

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Respiratory Tract Infections
Urologic Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action