Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

NCT02191475 | Unknown Phase 2 DMC

• 1 other identifier: WDH2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Infection

Keywords

sepsis shock; Tigecycline; Piperacillin / tazobactam; Abdominal infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs

  2 weeks

Other Outcomes (1)

• Residence time and expenses in ICU

  2 weeks

Study Arms (2)

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.

Drug: glycopeptide plus carbapenem

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.

Drug: Haizheng Li Xing ® plus tazocin ®

Interventions

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

Also known as: The clinical curative effect

glycopeptide plus carbapenem

Haizheng Li Xing ® plus tazocin ® DRUG

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

Also known as: The clinical curative effect

Haizheng Li Xing ® plus tazocin ®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Zhejiang Hisun Pharmaceutical Co. Ltd.: collaborator

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 22408344 BACKGROUND

• 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.

  PMID: 23772043 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.

  PMID: 17359318 RESULT

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Glycopeptides; Carbapenems; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Wang Donghao, Chief

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Wang Donghao, chief

CONTACT

022-23340123; donghaow@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 16, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 16, 2014

Record last verified: 2014-05

Locations

CN (1)