drugset / Trial / NCT02191475
Effect Study of Tigecycline to Treat Severe Sepsis and Septic Shock
Phase 2/3
Unknown
100 enrolled
Tianjin Medical University Cancer Institute and Hospital
Zhejiang Hisun Pharmaceutical Co. Ltd. · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2017-05
- Completion
- 2017-05
Publications
- Background 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 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Linezolid | Other / unclassified | 300 mg | Intravenous |
| Comparator | Meropenem | Small molecule | 1 g | Intravenous |
| Subject | Tigecycline | Small molecule | 50 mg | — |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | imipenem/cilastatin | Unknown | 500 mg | Intravenous |
| Subject | piperacillin/tazobactam | Other / unclassified | 4.5 g | Intravenous |