Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection (PIP-SBT)
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 December 2012 by Xiangbei Welman Pharmaceutical Co., Ltd.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Xiangbei Welman Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01760109
First Posted: January 3, 2013
Last Update Posted: January 3, 2013
Information provided by (Responsible Party):
Xiangbei Welman Pharmaceutical Co., Ltd
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Purpose
In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
| Condition | Intervention | Phase |
|---|---|---|
| Respiratory Tract Infections Urinary Tract Infections | Drug: Piperacillin Sodium and Sulbactam Sodium | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection |
Resource links provided by NLM:
Further study details as provided by Xiangbei Welman Pharmaceutical Co., Ltd:
Primary Outcome Measures:
- The rate of bacterial clearance [ Time Frame: two years ]end of treatment of bacteriological efficacy(bactercial clearance) The fore-and-aft changes of clinical symptoms and signs after discontinuation of durgs
Secondary Outcome Measures:
- Number of participants with Adverse Events [ Time Frame: two years ]the incidence(%)of allergies, skin rashes, shock,death, etc.
| Estimated Enrollment: | 2000 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Piperacillin Sodium and Sulbactam Sodium
Drug:xintemie 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days |
Drug: Piperacillin Sodium and Sulbactam Sodium
1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
Other Names:
|
Detailed Description:
Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.
Eligibility
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01760109
Contacts
| Contact: Ting Wang, doctor | 020-38868707 | wmrd@welman.com.cn | |
| Contact: Rong Lin, bachelor | 020-38868707 | linrong@welman.com.cn |
Locations
| China | |
| Chongqing Red Cross hospital | Recruiting |
| Chongqing, China, 400020 | |
| Contact: Changqing Li, doctor (023)88519201 | |
| Sub-Investigator: Changqing Li, doctor | |
Sponsors and Collaborators
Xiangbei Welman Pharmaceutical Co., Ltd
Investigators
| Principal Investigator: | Changqing Li, doctor | Chongqing Red Cross Hospital |
More Information
| Responsible Party: | Xiangbei Welman Pharmaceutical Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01760109 History of Changes |
| Other Study ID Numbers: |
2002HL0153 |
| First Submitted: | December 19, 2012 |
| First Posted: | January 3, 2013 |
| Last Update Posted: | January 3, 2013 |
| Last Verified: | December 2012 |
Keywords provided by Xiangbei Welman Pharmaceutical Co., Ltd:
|
Respiratory and urinary tract infections Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) Phase IV |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Urinary Tract Infections Respiratory Tract Infections Urologic Diseases Respiratory Tract Diseases Piperacillin |
Sulbactam Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |