Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

March 20, 2019 updated by: Paratek Pharmaceuticals Inc

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (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)

655

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

  • Bulgaria
      • Pleven, Bulgaria
        • Site 104
      • Plovdiv, Bulgaria
        • Site 102
      • Plovdiv, Bulgaria
        • Site 105
      • Rousse, Bulgaria
        • Site 103
      • Sofia, Bulgaria
        • Site 101
  • Croatia
      • Slavonski Brod, Croatia
        • Site 205
      • Zagreb, Croatia
        • Site 202
      • Zagreb, Croatia, 10000
        • Site 201
      • Zagreb, Croatia, 10000
        • Site 203
      • Zagreb, Croatia
        • Site 204
  • Greece
      • Athens, Greece
        • Site 207
      • Athens, Greece
        • Site 211
      • Thessaloniki, Greece
        • Site 208
      • Thessaloniki, Greece
        • Site 209
  • Hungary
      • Budapest, Hungary
        • Site 110
      • Budapest, Hungary
        • Site 111
      • Miskolc, Hungary
        • Site 114
      • Szeged, Hungary
        • Site 113
  • Israel
      • Holon, Israel
        • Site 213
      • Kfar-Saba, Israel
        • Site 219
      • Nazareth, Israel
        • Site 214
      • Safed, Israel
        • Site 216
  • Latvia
      • Daugavpils, Latvia
        • Site 122
      • Liepaja, Latvia
        • Site 123
      • Rezekne, Latvia
        • Site 124
      • Riga, Latvia
        • Site 120
      • Riga, Latvia
        • Site 121
  • Peru
      • Cusco, Peru
        • Site 234
      • Lima, Peru
        • Site 233
      • Lima, Peru
        • Site 236
      • Lima, Peru
        • Site 238
      • Lima, Peru
        • Site 239
      • Trujillo, Peru
        • Site 237
  • Poland
      • Bydgoszcz, Poland
        • Site 130
      • Katowice, Poland
        • Site 133
      • Lodz, Poland
        • Site 131
      • Olsztyn, Poland
        • Site 134
      • Warszawa, Poland
        • Site 132
  • Romania
      • Bucharest, Romania
        • Site 141
      • Bucharest, Romania
        • Site 142
      • Bucharest, Romania
        • Site 146
      • Cluj-Napoca, Romania
        • Site 144
      • Craiova, Romania
        • Site 140
      • Timisoara, Romania
        • Site 145
      • Târgu-Mureş, Romania
        • Site 143
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa
        • Site 241
    • Limpopo
      • Thabazimbi, Limpopo, South Africa
        • Site 244
  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Site 222
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Site 221
  • Turkey
      • Ankara, Turkey
        • Site 247
      • Trabzon, Turkey
        • Site 246
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Site 172
      • Dnipropetrovsk, Ukraine
        • Site 173
      • Kharkiv, Ukraine
        • Site 179
      • Kyiv, Ukraine
        • Site 171
      • Lviv, Ukraine
        • Site 170
      • Odesa, Ukraine
        • Site 174
      • Uzhhorod, Ukraine
        • Site 175
      • Vinnytsia, Ukraine
        • Site 178
      • Zaporizhia, Ukraine
        • Site 176
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Site 261
    • California
      • Chula Vista, California, United States, 91911
        • Site 262
      • La Mesa, California, United States, 91942
        • Site 254
      • Oceanside, California, United States, 92056
        • Site 258
      • Santa Ana, California, United States, 92705
        • Site 252
      • Santa Ana, California, United States, 92705
        • Site 260
      • Stockton, California, United States, 95204
        • Site 269
    • Florida
      • Miami, Florida, United States, 33144
        • Site 259
      • West Palm Beach, Florida, United States, 33407
        • Site 264
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Site 256
      • Columbus, Georgia, United States, 31904
        • Site 253
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Site 257
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Site 268
    • Montana
      • Butte, Montana, United States, 59701
        • Site 266
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Site 263
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • Site 270
    • New York
      • Buffalo, New York, United States, 14215
        • Site 273
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Site 255

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 treatment and procedures, that require antibacterial treatment for greater than 14 days
  • Evidence of significant immunological disease
  • Severe sepsis or septic shock
  • Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
  • Has received an investigational drug within 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omadacycline
Omadacycline IV; Omadacycline tablets
Drug: Omadacycline
Injection for IV dosing; Tablets for oral dosing
ACTIVE_COMPARATOR: Linezolid
Linezolid IV; Linezolid tablets
Drug: Linezolid
Infusion solution for IV dosing; Tablets for oral dosing
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; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These 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. Indeterminate: 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; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These 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.
Screening; 7 to 14 days after the last day of therapy
Number of Participants With the Indicated Type of Adverse Event (AE)
Time Frame: 0 to 37 days
An AE is defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. A serious adverse event (SAE) is defined as an event that resulted in death, was life-threatening, required hospitalization or prolongation of an existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in cancer, or resulted in a congenital anomaly or birth defect. A treatment-emergent AE (TEAE) is defined as any AE that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article. Vital sign measurements, electrocardiogram findings, and laboratory values classified as adverse events were included in the analysis. Data are presented as the number of participants with at least 1 of the event.
0 to 37 days

Collaborators and Investigators

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

Sponsor

Paratek Pharmaceuticals Inc

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

June 1, 2015

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (ESTIMATE)

March 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTK0796-ABSI-1108

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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