Respiratory Tract Infections, Urinary Tract Infections
Conditions
Keywords
Respiratory and urinary tract infections, Piperacillin Sodium and Sulbactam Sodium for Injection (2:1), Phase IV
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.
Interventions
DRUGPiperacillin 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
Sponsors
Xiangbei Welman Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of bacterial clearance | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | two years | the incidence(%)of allergies, skin rashes, shock,death, etc. |
Countries
China
Outcome results
None listed