Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Phase 2

• Conditions: Abdominal Infection
• Interventions: Drug: glycopeptide plus carbapenem; Drug: Haizheng Li Xing ® plus tazocin ®

• Registration Number: NCT02191475
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-07-13
• Last Update Submitted: 2014-07-13
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glycopeptide plus carbapenem	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.
Haizheng Li Xing ® plus tazocin ®	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment between Tigecycline plus tazocin and classic anti infection method	2 weeks	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

Name	Time	Method
Successful rate between two groups with abnormal renal function and liver function abnormalities which should adjust dose of drugs	2 weeks	Evaluation of two groups of patients EGDT treatment compliance rate, mortality rate (the success rate of treatment), ICU stay time.

Trial Locations

Locations (1)

TianjinCIH; 🇨🇳 Tianjin, Tianjin, China