Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock (Tigecycline)

Tigecycline (Hai Zheng Li Xing®) Combined With Piperacillin/Tazobactam (Tazocin ®) Empirical Treatment of Severe Sepsis and Septic Shock in Patients With Abdominal Infection

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Infection
• Intervention / Treatment: Drug: glycopeptide plus carbapenem; Drug: Haizheng Li Xing ® plus tazocin ®

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Wang Donghao, Chief; Phone Number: 1021 022-23340123; Email: donghaow@medmail.com.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • TianjinCIH
      • Contact: Wang Donghao, Chief; Phone Number: 1021 022-23340123; Email: donghaow@medmail.com.cn
      • Contact: Wang Donghao Donghao, Chief; Phone Number: 1021 022-23340123; Email: donghaow@medmail.com.cn
      • Sub-Investigator: Lv Yang, physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Investigators: Study Chair: Wang Donghao, Chief, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: July 13, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Tigecycline; sepsis shock; Piperacillin / tazobactam; Abdominal infection
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Infections; Intraabdominal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: WDH2014