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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was:  Enrolling by invitation
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd Identifier:
First received: August 23, 2011
Last updated: September 10, 2012
Last verified: September 2012
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 Intervention Phase
Respiratory Tract Infections Urinary Tract Infections Drug: xinzhijun Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Xiangbei Welman Pharmaceutical Co., Ltd:

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

Estimated Enrollment: 2000
Study Start Date: August 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd Identifier: NCT01426191     History of Changes
Other Study ID Numbers: 20090095
Study First Received: August 23, 2011
Last Updated: September 10, 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 processed this record on August 17, 2017