NCT02784704

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (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 (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).

Conditions

• Complicated Intra-abdominal Infections
• Complicated Appendicitis

Interventions

Type	Name	Description
DRUG	Eravacycline
DRUG	Meropenem
DRUG	Placebo

Timeline

• Start date: 2016-10-13
• Primary completion: 2017-05-08
• Completion: 2017-05-19
• First posted: 2016-05-27
• Last updated: 2022-01-06
• Results posted: 2019-02-18

Locations

54 sites across 11 countries: United States, Bulgaria, Czechia, Estonia, Georgia, Hungary, Latvia, Lithuania, Romania, Russia, Ukraine