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Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

NCT02378480 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2019-03-21

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

Conditions

Interventions

DRUG

Omadacycline

Injection for IV dosing; Tablets for oral dosing

DRUG

Linezolid

Infusion solution for IV dosing; Tablets for oral dosing

Sponsors & Collaborators

  • Paratek 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
2015-06-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • United States
  • Bulgaria
  • Croatia
  • Greece
  • Hungary
  • Israel
  • Latvia
  • Peru
  • Poland
  • Romania
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Entities

Diseases

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 NCT02378480 on ClinicalTrials.gov