Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection (SWSB)
In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime 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.
Respiratory Tract Infections
Urinary Tract Infections
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection|
- overall effect [ Time Frame: two year ] [ Designated as safety issue: No ]
end of treatment of bacteriological efficacy(bacterial clearance)
The fore-and-aft changes of clinical symptoms and signs after discontinuation of drugs
- Number of participants with Adverse Events [ Time Frame: two year ] [ Designated as safety issue: No ]the incidence(%)of allergies, skin rashes, shock,death, etc.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
1.5-3.0g,iv,bid or tid for 5-12 days
durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)
1.5-3.0g,iv,bid or tid for 5-12 days;
Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days
Cefotaxime is a third-generation cephalosporins.Cefotaxime 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 cefotaxime in the treatment-resistant pathogen infections.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426191
|Principal Investigator:||lanjuan lj li, docter||Zhejiang University|
|Study Director:||changqing cq li, doctor||Chongqing Red Cross Hospital|