Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock

Abdominal Infection Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02191475
• Other study ID #: WDH2014
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 24, 2014
• Last updated: July 13, 2014
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2014
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Wang Donghao, chief
• Phone: 022-23340123
• Email: donghaow[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

• APACHE? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Infection
• Infection
• Intraabdominal Infections

Intervention

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

Locations

Country	Name	City	State
China	TianjinCIH	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Zhejiang Hisun Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

References & Publications (3)

Eckmann C, Montravers P, Bassetti M, Bodmann KF, Heizmann WR, Sánchez García 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 Eur — View Citation

Hawkey P, Finch R. Tigecycline: in-vitro performance as a predictor of clinical efficacy. Clin Microbiol Infect. 2007 Apr;13(4):354-62. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residence time and expenses in ICU	Patients with ICU residence time and expenses have no difference between the two groups.	2 weeks	Yes
Primary	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	Yes
Secondary	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	Yes