Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Condition(s) targeted: Abdominal Infection

Intervention: glycopeptide plus carbapenem (Drug); Haizheng Li Xing ® plus tazocin ® (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Tianjin Medical University Cancer Institute and Hospital

Official(s) and/or principal investigator(s):
Wang Donghao, Chief, Study Chair, Affiliation: Tianjin Medical University Cancer Institute and Hospital

Overall contact:
Wang Donghao, chief, Phone: 022-23340123, Ext: 1021, Email: donghaow@medmail.com.cn

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method

Secondary outcome: Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be consistent with severe sepsis and septic shock diagnosis standards

- Age above 18 years old, is expected in more than 5 days in ICU

- APACHEâ…¡ score>15

- By the patients themselves or their authorized person agreed to participate in the

clinical trial and signed the informed consent Exclusion Criteria:

- Allergic to penicillin, or of tigecycline allergic patients

- Patients with abnormal liver function is severe

- Be pregnant or lactating women

- Be not signed the informed consent of patients

- Any can be expected to increase patient risk or other factors can interfere with the

results of a clinical trial

Wang Donghao, chief, Phone: 022-23340123, Ext: 1021, Email: donghaow@medmail.com.cn

TianjinCIH, Tianjin, Tianjin 300060, China; Recruiting
Wang Donghao, Chief, Phone: 022-23340123, Ext: 1021, Email: donghaow@medmail.com.cn
Wang Donghao Donghao, Chief, Phone: 022-23340123, Ext: 1021, Email: donghaow@medmail.com.cn
Lv Yang, physician, Sub-Investigator

Related publications:

Sartelli M, Catena F, Coccolini F, Pinna AD. Antimicrobial management of intra-abdominal infections: literature's guidelines. World J Gastroenterol. 2012 Mar 7;18(9):865-71. doi: 10.3748/wjg.v18.i9.865.

Starting date: May 2014
Last updated: July 13, 2014