drugset / Trial / NCT01978938

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

NCT01978938

Phase 3 Completed 908 enrolled Tetraphase Pharmaceuticals, Inc
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2014-10-06
Primary completion
2015-06-03
Completion
2015-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Eravacycline Small molecule 1.5 mg/kg Intravenous
Subject Eravacycline Small molecule 200 mg Intravenous
Subject Eravacycline Small molecule 250 mg Intravenous
Comparator Levofloxacin Small molecule 750 mg Intravenous