NCT01601093

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

Phase Ⅱ Study on Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Xiangbei Welman Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In the proposed study, the investigators plan to evaluate the efficacy and safety of Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.

Detailed description

Ceftazidime is a third-generation cephalosporins. Ceftazidime 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 ceftazidime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftazidime in the treatment-resistant pathogen infections.

Conditions

• Respiratory Tract Infections
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	High dose	Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
DRUG	Low dose	Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
DRUG	Cefoperazone and Sulbactam Sodium (CFP/SUB)	Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.

Timeline

• Start date: 2011-11-01
• Primary completion: 2022-08-15
• Completion: 2022-12-15
• First posted: 2012-05-17
• Last updated: 2019-07-05

Locations

1 site across 1 country: China