Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
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)
1 other identifier
interventional
735
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2016
Shorter than P25 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2017
CompletedResults Posted
Study results publicly available
November 30, 2018
CompletedNovember 30, 2018
November 1, 2018
10 months
August 15, 2016
November 2, 2018
November 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Screening; 48 to 72 hours after the first dose of test article
Secondary Outcomes (2)
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
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
Screening; 7 to 14 days after the last day of therapy
Study Arms (2)
Omadacycline
EXPERIMENTALOmadacycline tablets
Linezolid
ACTIVE COMPARATORLinezolid tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Site 620
Birmingham, Alabama, 35215, United States
Site 642
Mobile, Alabama, 36608, United States
Site 616
Anaheim, California, 92801, United States
Site 601
Anaheim, California, 92804, United States
Site 636
Bakersfield, California, 93301, United States
Site 606
Buena Park, California, 90620, United States
Site 604
Chula Vista, California, 91911, United States
Site 659
Huntington Beach, California, 92647, United States
Site 608
La Mesa, California, 91942, United States
Site 618
Laguna Hills, California, 92653, United States
Site 612
Long Beach, California, 90813, United States
Site 648
Modesto, California, 95350, United States
Site 610
Oceanside, California, 92056, United States
Site 615
San Diego, California, 92114, United States
Site 621
San Diego, California, 92119, United States
Site 613
San Francisco, California, 94115, United States
Site 603
Stockton, California, 95204, United States
Site 650
Torrance, California, 90502, United States
Site 646
Ventura, California, 93003, United States
Site 614
DeLand, Florida, 32720, United States
Site 655
Fort Myers, Florida, 33901, United States
Site 656
Homestead, Florida, 33030, United States
Site 631
Miami, Florida, 33015, United States
Site 658
Miami, Florida, 33125, United States
Site 654
Miami, Florida, 33134, United States
Site 626
Miami, Florida, 33144, United States
Site 637
Miami, Florida, 33144, United States
Site 653
Miami, Florida, 33145, United States
Site 641
Miami, Florida, 33175, United States
Site 645
Miami, Florida, 33175, United States
Site 640
Miami Lakes, Florida, 33016, United States
Site 662
Miami Lakes, Florida, 33104, United States
Site 609
Saint Cloud, Florida, 34769, United States
Site 644
Council Bluffs, Iowa, 51503, United States
Site 657
Boston, Massachusetts, 02115, United States
Site 617
St Louis, Missouri, 63128, United States
Site 602
Butte, Montana, 59701, United States
Site 623
Las Vegas, Nevada, 89109, United States
Site 630
Somers Point, New Jersey, 08244, United States
Site 647
Jackson Heights, New York, 11372, United States
Site 632
Mount Airy, North Carolina, 27030, United States
Site 649
Toledo, Ohio, 43608, United States
Site 607
Rapid City, South Dakota, 57702, United States
Site 635
Jackson, Tennessee, 38305, United States
Site 628
Smyrna, Tennessee, 37167, United States
Site 633
Baytown, Texas, 77521, United States
Site 605
Channelview, Texas, 77530, United States
Site 625
Houston, Texas, 77008, United States
Site 627
Houston, Texas, 77084, United States
Site 634
Sugar Land, Texas, 77479, United States
Related Publications (6)
Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials. Infect Dis Ther. 2024 Dec;13(12):2637-2648. doi: 10.1007/s40121-024-01057-3. Epub 2024 Oct 26.
PMID: 39461915DERIVEDVacalis 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.
PMID: 35776862DERIVEDPai 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.
PMID: 33458763DERIVEDCornely 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.
PMID: 33326848DERIVEDO'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.
PMID: 31474458DERIVEDAbrahamian 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.
PMID: 31367742DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul McGovern; Vice President, Clinical Affairs
- Organization
- Paratek Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Amy Manley
Senior Director, Clinical Operations
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 24, 2016
Study Start
August 1, 2016
Primary Completion
May 26, 2017
Study Completion
June 6, 2017
Last Updated
November 30, 2018
Results First Posted
November 30, 2018
Record last verified: 2018-11