Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

Phase 2 Completed 143 enrolled Tetraphase Pharmaceuticals, Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).

Timeline

Start: 2011-01
Primary completion: 2012-05
Completion: 2012-05

Publications

Solomkin JS, Ramesh MK, Cesnauskas G, Novikovs N, Stefanova P, Sutcliffe JA, Walpole SM, Horn PT. Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014;58(4):1847-54. doi: 10.1128/AAC.01614-13. Epub 2013 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eravacycline	Small molecule	1 mg/kg	Intravenous
Subject	Eravacycline	Small molecule	1.5 mg/kg	Intravenous
Comparator	Ertapenem	Small molecule	1 g	Intravenous

Indications

No indication recorded.