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Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Primary Purpose

Bacterial Infections, Skin Structures and Soft Tissue Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omadacycline
Linezolid
Sponsored by
Paratek Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 620
  • Site 642
  • Site 616
  • Site 601
  • Site 636
  • Site 606
  • Site 604
  • Site 659
  • Site 608
  • Site 618
  • Site 612
  • Site 648
  • Site 610
  • Site 615
  • Site 621
  • Site 613
  • Site 603
  • Site 650
  • Site 646
  • Site 614
  • Site 655
  • Site 656
  • Site 640
  • Site 662
  • Site 631
  • Site 658
  • Site 654
  • Site 626
  • Site 637
  • Site 653
  • Site 641
  • Site 645
  • Site 609
  • Site 644
  • Site 657
  • Site 617
  • Site 602
  • Site 623
  • Site 630
  • Site 647
  • Site 632
  • Site 649
  • Site 607
  • Site 635
  • Site 628
  • Site 633
  • Site 605
  • Site 625
  • Site 627
  • Site 634

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omadacycline

Linezolid

Arm Description

Omadacycline tablets

Linezolid tablets

Outcomes

Primary Outcome Measures

Number of Participants With Early Clinical Response
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

Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
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.
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
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.

Full Information

First Posted
August 15, 2016
Last Updated
November 28, 2018
Sponsor
Paratek Pharmaceuticals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02877927
Brief Title
Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
June 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Skin Structures and Soft Tissue Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
735 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omadacycline
Arm Type
Experimental
Arm Description
Omadacycline tablets
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
Linezolid tablets
Intervention Type
Drug
Intervention Name(s)
Omadacycline
Intervention Description
po tablets
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
po tablets
Primary Outcome Measure Information:
Title
Number of Participants With Early Clinical Response
Description
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.
Time Frame
Screening; 48 to 72 hours after the first dose of test article
Secondary Outcome Measure Information:
Title
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
Description
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.
Time Frame
Screening; 7 to 14 days after the last day of therapy
Title
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
Description
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.
Time Frame
Screening; 7 to 14 days after the last day of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Manley
Organizational Affiliation
Senior Director, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Site 620
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Site 642
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site 616
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site 601
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Site 636
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Site 606
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Site 604
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Site 659
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Site 608
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Site 618
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Site 612
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Site 648
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
Site 610
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site 615
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Site 621
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Site 613
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Site 603
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Site 650
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site 646
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Site 614
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site 655
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Site 656
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Site 640
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site 662
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33104
Country
United States
Facility Name
Site 631
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Site 658
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Site 654
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 626
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site 637
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site 653
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Site 641
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Site 645
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Site 609
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Site 644
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Site 657
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Site 617
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Site 602
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Site 623
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Site 630
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Site 647
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Facility Name
Site 632
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Site 649
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Site 607
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Site 635
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site 628
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Site 633
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Site 605
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
Site 625
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Site 627
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Site 634
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35776862
Citation
Vacalis S, Brunton S, Gindi J. Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence. J Fam Pract. 2022 Jun;71(5 Suppl):S10-S21. doi: 10.12788/jfp.0424.
Results Reference
derived
PubMed Identifier
33458763
Citation
Pai MP, Wilcox MH, Chitra S, McGovern PC. Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections. J Antimicrob Chemother. 2021 Apr 13;76(5):1315-1322. doi: 10.1093/jac/dkaa558.
Results Reference
derived
PubMed Identifier
33326848
Citation
Cornely OA, File TM Jr, Garrity-Ryan L, Chitra S, Noble R, McGovern PC. Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild-to-moderate renal impairment. Int J Antimicrob Agents. 2021 Feb;57(2):106263. doi: 10.1016/j.ijantimicag.2020.106263. Epub 2020 Dec 14.
Results Reference
derived
PubMed Identifier
31474458
Citation
O'Riordan W, Cardenas C, Shin E, Sirbu A, Garrity-Ryan L, Das AF, Eckburg PB, Manley A, Steenbergen JN, Tzanis E, McGovern PC, Loh E; OASIS-2 Investigators. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019 Oct;19(10):1080-1090. doi: 10.1016/S1473-3099(19)30275-0. Epub 2019 Aug 29.
Results Reference
derived
PubMed Identifier
31367742
Citation
Abrahamian FM, Sakoulas G, Tzanis E, Manley A, Steenbergen J, Das AF, Eckburg PB, McGovern PC. Omadacycline for Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S23-S32. doi: 10.1093/cid/ciz396.
Results Reference
derived

Learn more about this trial

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

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