Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Haizheng Li Xing ® plus tazocin ®

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

glycopeptide plus carbapenem

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Haizheng Li Xing ® plus tazocin ®

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

Intervention Type DRUG

Other Intervention Names

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The clinical curative effect The clinical curative effect

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No