NCT03032510

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,205 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).

Detailed description

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI). 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 cUTI. Randomization will be stratified based on two criteria: (1) by primary site of infection (pyelonephritis and normal urinary tract anatomy vs all other diagnoses) and (2) by the receipt of a single dose of effective non-study antibiotics for the acute cUTI within 72 hours prior to randomization. An enrollment cap of approximately 50% is planned for subjects with pyelonephritis with normal urinary tract anatomy. Also, an enrollment cap of approximately 20% is planned for subjects who have received a single dose of non-study antibiotics for the acute cUTI within 72 hours prior to randomization. In this study subjects will be enrolled and randomized to one of two treatment arms in a 1:1 ratio: (i) eravacycline intravenously (IV) / levofloxacin (PO), or (ii) ertapenem (IV) / levofloxacin (PO).

Conditions

• Complicated Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Eravacycline
DRUG	Ertapenem
DRUG	Placebo
DRUG	Levofloxacin

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2017-01-26
• Last updated: 2022-01-06
• Results posted: 2019-10-02

Locations

69 sites across 12 countries: United States, Austria, Bulgaria, Estonia, Georgia, Hungary, Latvia, Moldova, Romania, Russia, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study