Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection (PIP-SBT)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01760109 |
Recruitment Status :
Completed
First Posted : January 3, 2013
Last Update Posted : July 8, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Tract Infections Urinary Tract Infections | Drug: Piperacillin Sodium and Sulbactam Sodium | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2000 participants |
Allocation: | N/A |
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 |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
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:
|
- 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
- Number of participants with Adverse Events [ Time Frame: two years ]the incidence(%)of allergies, skin rashes, shock,death, etc.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
China | |
Chongqing Red Cross hospital | |
Chongqing, China, 400020 |
Principal Investigator: | Changqing Li, doctor | Chongqing Red Cross Hospital |
Responsible Party: | Xiangbei Welman Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01760109 |
Other Study ID Numbers: |
2002HL0153 |
First Posted: | January 3, 2013 Key Record Dates |
Last Update Posted: | July 8, 2019 |
Last Verified: | July 2019 |
Respiratory and urinary tract infections Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) Phase IV |
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 |