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

NCT01426191 | Completed Results DMC

• 1 other identifier: 20090095
• Study Type: observational
• Target: 2,032
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Keywords

Cefotaxime sulbactam sodium; Phase IV clinical studies; Respiratory and urinary tract infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

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

  day0-day22-28

Secondary Outcomes (1)

• Clinical Effect

  at weeks 4,day22-28

Study Arms (1)

xinzhijun

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

Drug: xinzhijun

Interventions

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

Also known as: Experimental, shumate

xinzhijun

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized patients or outpatients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Directer of clinical trials
• Organization: xiangbei welman pharmacuticol CO.,LTD

gap@welman.com.cn

020-38868707

Study Officials

• lanjuan lj li, docter

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• changqing cq li, doctor

  Chongqing Red Cross Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09