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

NCT03032510 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1205

Last updated 2022-01-06

Study results available
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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).

Conditions

  • Complicated Urinary Tract Infections

Interventions

DRUG

Eravacycline

DRUG

Ertapenem

DRUG

Placebo

DRUG

Levofloxacin

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Tetraphase Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-12-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Moldova
  • Romania
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT03032510 on ClinicalTrials.gov