NCT01978938

Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 908 (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 and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).

Detailed description

This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250 milligrams \[mg\]) of eravacycline to be used with intravenously (IV) administered eravacycline for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded Lead-in analysis.

Conditions

• cUTI

Interventions

Type	Name	Description
DRUG	Eravacycline
DRUG	Levofloxacin

Timeline

• Start date: 2014-10-06
• Primary completion: 2015-06-03
• Completion: 2015-08-21
• First posted: 2013-11-08
• Last updated: 2022-01-11
• Results posted: 2018-12-11

Locations

99 sites across 18 countries: United States, Bulgaria, Colombia, Czechia, Estonia, Georgia, Greece, Hungary, Israel, Italy, Latvia, Mexico, Moldova, Poland, Romania, Russia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study