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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 is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Paratek Pharmaceuticals Inc
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT02877927
First received: August 15, 2016
Last updated: March 1, 2017
Last verified: March 2017
  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: 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


Estimated Enrollment: 704
Study Start Date: August 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 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

  Eligibility

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
  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 ClinicalTrials.gov identifier: NCT02877927

Contacts
Contact: Alissa Sirbu alissa.sirbu@paratekpharma.com
Contact: Amy Manley amy.manley@paratekpharma.com

  Show 47 Study Locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Investigators
Study Director: Amy Manley Senior Director, Clinical Operations
  More Information

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02877927     History of Changes
Other Study ID Numbers: PTK0796-ABSI-16301
Study First Received: August 15, 2016
Last Updated: March 1, 2017

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

ClinicalTrials.gov processed this record on June 22, 2017