NCT02191475

Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Tigecycline (Hai Zheng Li Xing®) Combined With Piperacillin/Tazobactam (Tazocin ®) Empirical Treatment of Severe Sepsis and Septic Shock in Patients With Abdominal Infection

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme, compared with the classical scheme, evaluate its efficacy, safety index.

Detailed description

Tigecycline as representative glycylcycline antibiotics, has wide antibacterial spectrum and strong antibacterial activity, tigecycline in almost all of the gram positive bacteria and most gram negative bacteria and atypical pathogens, anaerobic bacteria are very good antibacterial activity except Pseudomonas aeruginosa, Proteus. Safety on organ function, in patients with renal insufficiency or in dialysis patients, no dose adjustment is required application of tigecycline, mild to moderate hepatic insufficiency patients do not need to adjust the dose of tigecycline. Piperacillin / tazobactam also is a broad spectrum, potent antibiotics, especially strong bactericidal activity against Pseudomonas aeruginosa, including resistant enzyme producing gram negative bacilli, in accordance with its pharmacokinetic pharmacodynamic characteristics of prolonged infusion time can obtain a stronger bactericidal activity. These two potent drugs have broad antimicrobial spectrum, strong bactericidal activity, and provide for the treatment of severe sepsis and septic shock a new choice in antibiotic selection, to a certain extent reduces the resistance pressure, and have more clinical safety.

Conditions

• Abdominal Infection

Interventions

Type	Name	Description
DRUG	glycopeptide plus carbapenem	The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy
DRUG	Haizheng Li Xing ® plus tazocin ®	Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-07-16
• Last updated: 2014-07-16

Locations

1 site across 1 country: China