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

Phase 4

• Conditions: Respiratory Tract Infections; Urinary Tract Infections
• Interventions: Drug: xin te mie

• Registration Number: NCT01897831
• Lead Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd

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 under the widely used in clinical conditions.

Detailed Description

Piperacillin 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 Piperacillin in the treatment-resistant pathogen infections.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-09
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12
• Primary Completion: 2015-08
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
xin te mie	xin te mie	1.5-3.0g,iv,bid or tid for 7-14 days

Primary Outcome Measures

Name	Time	Method
overall effect	two year	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

Name	Time	Method
Number of participants with Adverse Events	two year	the incidence(%)of allergies, skin rashes, shock,death, etc.