Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Abdominal Infection

Treatments: Drug: Haizheng Li Xing ® plus tazocin ®; Drug: glycopeptide plus carbapenem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02191475

WDH2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

glycopeptide plus carbapenem

Active Comparator group

Description:

The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy, dose of imipenem/cilastatin 500mg, IVdrip, 3\~4 times/d, or meropenem 1g, IVdrip, 3 times/d; vancomycin for 15mg/kg,2 times/d, or linezolid 300mg, IVdrip, 2 times/d; these drugs are required to state organ function in patients with drug doses adjustment, treatment for 3-5 days.

Treatment:

Drug: glycopeptide plus carbapenem

Haizheng Li Xing ® plus tazocin ®

Experimental group

Description:

Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy, dose of tigecycline first dose 100 mg, 50 mg, every 12 hours, piperacillin / tazobactam 4.5g, ivdrip, 3-4 times a day, each time the infusion of 3 hours, treatment for 3-5 days.

Treatment:

Drug: Haizheng Li Xing ® plus tazocin ®