Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

November 28, 2018 updated by: Paratek Pharmaceuticals Inc

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

735

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Site 620
      • Mobile, Alabama, United States, 36608
        • Site 642
    • California
      • Anaheim, California, United States, 92801
        • Site 616
      • Anaheim, California, United States, 92804
        • Site 601
      • Bakersfield, California, United States, 93301
        • Site 636
      • Buena Park, California, United States, 90620
        • Site 606
      • Chula Vista, California, United States, 91911
        • Site 604
      • Huntington Beach, California, United States, 92647
        • Site 659
      • La Mesa, California, United States, 91942
        • Site 608
      • Laguna Hills, California, United States, 92653
        • Site 618
      • Long Beach, California, United States, 90813
        • Site 612
      • Modesto, California, United States, 95350
        • Site 648
      • Oceanside, California, United States, 92056
        • Site 610
      • San Diego, California, United States, 92114
        • Site 615
      • San Diego, California, United States, 92119
        • Site 621
      • San Francisco, California, United States, 94115
        • Site 613
      • Stockton, California, United States, 95204
        • Site 603
      • Torrance, California, United States, 90502
        • Site 650
      • Ventura, California, United States, 93003
        • Site 646
    • Florida
      • DeLand, Florida, United States, 32720
        • Site 614
      • Fort Myers, Florida, United States, 33901
        • Site 655
      • Homestead, Florida, United States, 33030
        • Site 656
      • Miami, Florida, United States, 33015
        • Site 631
      • Miami, Florida, United States, 33125
        • Site 658
      • Miami, Florida, United States, 33134
        • Site 654
      • Miami, Florida, United States, 33144
        • Site 626
      • Miami, Florida, United States, 33144
        • Site 637
      • Miami, Florida, United States, 33145
        • Site 653
      • Miami, Florida, United States, 33175
        • Site 641
      • Miami, Florida, United States, 33175
        • Site 645
      • Miami Lakes, Florida, United States, 33016
        • Site 640
      • Miami Lakes, Florida, United States, 33104
        • Site 662
      • Saint Cloud, Florida, United States, 34769
        • Site 609
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Site 644
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Site 657
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Site 617
    • Montana
      • Butte, Montana, United States, 59701
        • Site 602
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Site 623
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • Site 630
    • New York
      • Jackson Heights, New York, United States, 11372
        • Site 647
    • North Carolina
      • Mount Airy, North Carolina, United States, 27030
        • Site 632
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Site 649
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Site 607
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Site 635
      • Smyrna, Tennessee, United States, 37167
        • Site 628
    • Texas
      • Baytown, Texas, United States, 77521
        • Site 633
      • Channelview, Texas, United States, 77530
        • Site 605
      • Houston, Texas, United States, 77008
        • Site 625
      • Houston, Texas, United States, 77084
        • Site 627
      • Sugar Land, Texas, United States, 77479
        • Site 634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omadacycline
Omadacycline tablets
Drug: Omadacycline
po tablets
Active Comparator: Linezolid
Linezolid tablets
Drug: Linezolid
po tablets
Other Names:
  • Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening; 48 to 72 hours after the first dose of test article

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening; 7 to 14 days after the last day of therapy
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.
Screening; 7 to 14 days after the last day of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paratek Pharmaceuticals Inc

Investigators

  • Study Director: Amy Manley, Senior Director, Clinical Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTK0796-ABSI-16301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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