drugset / Trial / NCT02784704
Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).
Timeline
- Start
- 2016-10-13
- Primary completion
- 2017-05-08
- Completion
- 2017-05-19
Publications
- Results Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.
- Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eravacycline | Small molecule | 1 mg/kg | Intravenous |
| Comparator | Meropenem | Small molecule | 1 g | Intravenous |