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

Primary Purpose

Abdominal Infection

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
glycopeptide plus carbapenem
Haizheng Li Xing ® plus tazocin ®
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Infection focused on measuring sepsis shock, Tigecycline, Piperacillin / tazobactam, Abdominal infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TianjinCIHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

glycopeptide plus carbapenem

Haizheng Li Xing ® plus tazocin ®

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 24, 2014
Last Updated
July 13, 2014
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02191475
Brief Title
Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock
Acronym
Tigecycline
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Infection
Keywords
sepsis shock, Tigecycline, Piperacillin / tazobactam, Abdominal infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
glycopeptide plus carbapenem
Arm Type
Active Comparator
Arm 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.
Arm Title
Haizheng Li Xing ® plus tazocin ®
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
glycopeptide plus carbapenem
Other Intervention Name(s)
The clinical curative effect
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Haizheng Li Xing ® plus tazocin ®
Other Intervention Name(s)
The clinical curative effect
Intervention Description
Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy
Primary Outcome Measure Information:
Title
Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs
Description
Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Residence time and expenses in ICU
Description
Patients with ICU residence time and expenses have no difference between the two groups.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Donghao, chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Donghao, Chief
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
TianjinCIH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Donghao, Chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Wang Donghao Donghao, Chief
Phone
022-23340123
Ext
1021
Email
donghaow@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Lv Yang, physician

12. IPD Sharing Statement

Citations:
PubMed Identifier
22408344
Citation
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.
Results Reference
background
PubMed Identifier
23772043
Citation
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.
Results Reference
result
PubMed Identifier
17359318
Citation
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.
Results Reference
result

Learn more about this trial

Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

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