Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Phase 3UnknownNCT02191475

Tianjin Medical University Cancer Institute and Hospital100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Abdominal Infection

Interventions

glycopeptide plus carbapenemDRUG

The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy

Haizheng Li Xing ® plus tazocin ®DRUG

Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

TianjinCIH

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Two groups of patients were assessed anti infection treatment effect per day. Including: temperature, procalcitonin, blood routine, liver and kidney function, bacteriological evidence, hemodynamics Effects of Haizheng Li Xing ® combined with tazocin ® in clinical treatment is not inferior to the classical antibiotics scheme

Time frame: 2 weeks

Secondary Outcomes

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

Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.

Time frame: 2 weeks

Central Contacts

Wang Donghao, chief

CONTACT

022-23340123 donghaow@medmail.com.cn

Data from ClinicalTrials.gov

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