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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
  Purpose

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: two year ] [ Designated as safety issue: No ]
    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
xinzhijun
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospitalized patients or outpatients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426191

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

No publications provided

Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01426191     History of Changes
Other Study ID Numbers: 20090095
Study First Received: August 23, 2011
Last Updated: September 10, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Respiratory Tract Infections
Urinary Tract Infections
Infection
Respiratory Tract Diseases
Urologic Diseases
Cefotaxime
Cefoxitin
 Sulbactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013