Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02191475

Collaborator

Zhejiang Hisun Pharmaceutical Co. Ltd. (Industry)

100

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Infection	Drug: glycopeptide plus carbapenem Drug: Haizheng Li Xing ® plus tazocin ®	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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, 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.	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 Other Names: The clinical curative effect
Experimental: Haizheng Li Xing ® plus tazocin ® 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.	Drug: Haizheng Li Xing ® plus tazocin ® Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy Other Names: The clinical curative effect

Arm

Intervention/Treatment

Active Comparator: 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, 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.

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

Other Names:

The clinical curative effect

Experimental: Haizheng Li Xing ® plus tazocin ®

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.

Drug: Haizheng Li Xing ® plus tazocin ®

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

Other Names:

The clinical curative effect

Outcome Measures

Primary Outcome Measures

Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method [2 weeks]
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

Secondary Outcome Measures

Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs [2 weeks]
Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.

Other Outcome Measures

Residence time and expenses in ICU [2 weeks]
Patients with ICU residence time and expenses have no difference between the two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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