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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02378480
First Posted: March 4, 2015
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc
  Purpose
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.

Condition Intervention Phase
Bacterial Infections Skin Structures and Soft Tissue Infections Drug: Omadacycline Drug: Linezolid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Resource links provided by NLM:


Further study details as provided by Paratek Pharmaceuticals Inc:

Primary Outcome Measures:
  • Early Clinical response, defined as survival with at least a 20% reduction of ABSSSI lesion size compared to screening measurements. [ Time Frame: 48-72 hours ]
  • Investigator assessment of clinical response, defined as survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit [ Time Frame: 7-14 days after the last day of therapy ]

Secondary Outcome Measures:
  • Safety and tolerability as assessed by adverse events, vital sign measurements, ECGs, and lab values [ Time Frame: 0-37 days ]

Estimated Enrollment: 650
Study Start Date: June 2015
Study Completion Date: May 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omadacycline
Omadacycline IV; Omadacycline tablets
Drug: Omadacycline
Injection for IV dosing; Tablets for oral dosing
Active Comparator: Linezolid
Linezolid IV; Linezolid tablets
Drug: Linezolid
Infusion solution for IV dosing; Tablets for oral dosing
Other Name: Zyvox

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, ages 18 years or older who have signed the informed consent
  • Has a qualifying skin and skin structure infection
  • Female patients must not be pregnant at the time of enrollment
  • Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

  • Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
  • Evidence of significant immunological disease
  • Severe sepsis or septic shock
  • Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
  • Has received an investigational drug within past 30 days
  • Women who are pregnant or nursing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378480


  Show 78 Study Locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
  More Information

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02378480     History of Changes
Other Study ID Numbers: PTK0796-ABSI-1108
First Submitted: February 19, 2015
First Posted: March 4, 2015
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Soft Tissue Infections
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action