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

NCT01978938 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 908

Last updated 2022-01-11

Study results available
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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).

Conditions

  • cUTI

Interventions

DRUG

Eravacycline

DRUG

Levofloxacin

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-06
Primary Completion
2015-06-03
Completion
2015-08-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Czechia
  • Estonia
  • Georgia
  • Greece
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Russia
  • South Africa
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01978938 on ClinicalTrials.gov