Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection (PIP-SBT)

• ClinicalTrials.gov Identifier: NCT01760109
• Recruitment Status: Completed
• First Posted: January 3, 2013
• Last Update Posted: July 8, 2019
• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
• Information provided by (Responsible Party): Xiangbei Welman Pharmaceutical Co., Ltd

Tracking Information

• First Submitted Date: December 19, 2012
• First Posted Date: January 3, 2013
• Last Update Posted Date: July 8, 2019
• Study Start Date: July 2011
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 30, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 30, 2012)

Number of participants with Adverse Events [ Time Frame: two years ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
• Official Title: Phase IV Study on Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Respiratory Tract Infections
• Urinary Tract Infections

Intervention

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:

• xin te mie
• te mie jun
• xin ke jun

Study Arms

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

Intervention: Drug: Piperacillin Sodium and Sulbactam Sodium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2012): 2000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01760109
• Other Study ID Numbers: 2002HL0153
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xiangbei Welman Pharmaceutical Co., Ltd
• Study Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
• Collaborators: Not Provided

Investigators

• Principal Investigator: Changqing Li, doctor; Chongqing Red Cross Hospital

• PRS Account: Xiangbei Welman Pharmaceutical Co., Ltd
• Verification Date: July 2019