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Trial record 1 of 5 for:    omadacycline
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Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

This study has been completed.
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc Identifier:
First received: August 15, 2016
Last updated: July 13, 2017
Last verified: July 2017
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 Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Resource links provided by NLM:

Further study details as provided by Paratek Pharmaceuticals Inc:

Primary Outcome Measures:
  • 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 ]
  • 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

Enrollment: 735
Study Start Date: August 2016
Study Completion Date: June 6, 2017
Primary Completion Date: May 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omadacycline
Omadacycline tablets
Drug: Omadacycline
po tablets
Active Comparator: Linezolid
Linezolid tablets
Drug: Linezolid
po tablets
Other Name: Zyvox


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02877927

  Show 50 Study Locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Study Director: Amy Manley Senior Director, Clinical Operations
  More Information

Responsible Party: Paratek Pharmaceuticals Inc Identifier: NCT02877927     History of Changes
Other Study ID Numbers: PTK0796-ABSI-16301
Study First Received: August 15, 2016
Last Updated: July 13, 2017

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Soft Tissue Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017