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

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: NCT02378480
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 655 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 Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Study Start Date : June 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

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 Name: Zyvox




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; 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.

  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; 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.

  3. 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.



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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 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

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): NCT02378480


Locations
Show Show 78 study locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02378480    
Other Study ID Numbers: PTK0796-ABSI-1108
First Posted: March 4, 2015    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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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