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| Name | Class |
|---|---|
| Zhejiang Hisun Pharmaceutical Co. Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glycopeptide plus carbapenem | Active Comparator | 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. |
|
| Haizheng Li Xing ® plus tazocin ® | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycopeptide plus carbapenem | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Residence time and expenses in ICU | Patients with ICU residence time and expenses have no difference between the two groups. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Donghao, chief | Contact | 022-23340123 | 1021 | donghaow@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang Donghao, Chief | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TianjinCIH | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22408344 | Background | 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. | |
| 23772043 | Result | 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. |
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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D015780 | Carbapenems |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Haizheng Li Xing ® plus tazocin ® | Drug | Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy |
|
|
| 17359318 | Result | 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. |
| D047090 |
| beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |