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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
Results First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Study Description
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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 Design
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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
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Early Clinical Response [ Time Frame: Screening; 48 to 72 hours after the first dose of test article ]
    Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.


Secondary Outcome Measures :
  1. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit [ Time Frame: Screening; 7 to 14 days after the last day of therapy ]
    At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason. Indeterminate The clinical response to test article could not be adequately inferred.

  2. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population [ Time Frame: Screening; 7 to 14 days after the last day of therapy ]
    At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Investigators
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Study Director: Amy Manley Senior Director, Clinical Operations
  Study Documents (Full-Text)

Documents provided by Paratek Pharmaceuticals Inc:
Study Protocol  [PDF] November 22, 2016
Statistical Analysis Plan  [PDF] May 24, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02877927    
Other Study ID Numbers: PTK0796-ABSI-16301
First Posted: August 24, 2016    Key Record Dates
Results First Posted: November 30, 2018
Last Update Posted: November 30, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Soft Tissue Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
 Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action