Clinical trial NCT02191475: Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Abdominal Infection
Keywords: sepsis shock
Tigecycline
Piperacillin / tazobactam
Abdominal infection
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Hisun Pharmaceutical Co. Ltd.
First posted: 2014-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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
* APACHEⅡ 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

Primary outcomes:
measure: Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method
timeFrame: 2 weeks
Secondary outcomes:
measure: Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs
timeFrame: 2 weeks
Other outcomes:
measure: Residence time and expenses in ICU
timeFrame: 2 weeks
Locations:
city: Tianjin
country: China
facility: TianjinCIH
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wang Donghao, Chief
role: STUDY_CHAIR
References:
citation: 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.
citation: Eckmann C, Montravers P, Bassetti M, Bodmann KF, Heizmann WR, Sanchez Garcia M, Guirao X, Capparella MR, Simoneau D, Dupont H. Efficacy of tigecycline for the treatment of complicated intra-abdominal infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii25-35. doi: 10.1093/jac/dkt142.
citation: Hawkey P, Finch R. Tigecycline: in-vitro performance as a predictor of clinical efficacy. Clin Microbiol Infect. 2007 Apr;13(4):354-62. doi: 10.1111/j.1469-0691.2006.01621.x.