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Trial record 1 of 6 for:    omadacycline
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Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

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.
ClinicalTrials.gov Identifier: NCT02877927
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Skin Structures and Soft Tissue Infections Drug: Omadacycline Drug: Linezolid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 735 participants
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 Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Study Start Date : August 2016
Primary Completion Date : May 26, 2017
Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Omadacycline
Omadacycline tablets
Drug: Omadacycline
po tablets
Active Comparator: Linezolid
Linezolid tablets
Drug: Linezolid
po tablets
Other Name: Zyvox



Primary Outcome Measures :
  1. Clinical success at the early clinical response assessment visit defined as survival with a greater than or equal to 20% reduction of lesion size [ Time Frame: 48-72 hours ]
  2. Clinical success at the post treatment evaluation visit defined as survival after completion of a test article regimen, with resolution of improvement of signs and symptoms of infection [ Time Frame: 7-14 days after the last day of therapy ]
    Signs and Symptoms of infection include presence of drainage, tenderness, edema, erythema, and induration



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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 treatments and procedures, or that require antibacterial treatment for greater than 14 days
  • Evidence of significant immunological disease
  • Severe renal disease or requirement for dialysis
  • Evidence of septic shock
  • Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
  • Has received an investigational drug within the past 30 days
  • Women who are pregnant or nursing

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): NCT02877927


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Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Investigators
Study Director: Amy Manley Senior Director, Clinical Operations

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02877927     History of Changes
Other Study ID Numbers: PTK0796-ABSI-16301
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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