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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
655

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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