NCT01844856

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Conditions

• Complicated Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	Eravacycline
DRUG	Ertapenem
DRUG	Placebo	Administered IV to maintain the blind.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-05-01
• Last updated: 2022-01-11
• Results posted: 2016-03-21

Locations

69 sites across 13 countries: United States, Argentina, Bulgaria, Czechia, Estonia, France, Germany, Latvia, Lithuania, Romania, Russia, South Africa, Ukraine