Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
NCT ID: NCT02877927
Last Updated: 2018-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
735 participants
INTERVENTIONAL
2016-08-31
2017-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Omadacycline
Omadacycline tablets
Omadacycline
po tablets
Linezolid
Linezolid tablets
Linezolid
po tablets
Interventions
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Omadacycline
po tablets
Linezolid
po tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Manley
Role: STUDY_DIRECTOR
Senior Director, Clinical Operations
Locations
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Site 620
Birmingham, Alabama, United States
Site 642
Mobile, Alabama, United States
Site 616
Anaheim, California, United States
Site 601
Anaheim, California, United States
Site 636
Bakersfield, California, United States
Site 606
Buena Park, California, United States
Site 604
Chula Vista, California, United States
Site 659
Huntington Beach, California, United States
Site 608
La Mesa, California, United States
Site 618
Laguna Hills, California, United States
Site 612
Long Beach, California, United States
Site 648
Modesto, California, United States
Site 610
Oceanside, California, United States
Site 615
San Diego, California, United States
Site 621
San Diego, California, United States
Site 613
San Francisco, California, United States
Site 603
Stockton, California, United States
Site 650
Torrance, California, United States
Site 646
Ventura, California, United States
Site 614
DeLand, Florida, United States
Site 655
Fort Myers, Florida, United States
Site 656
Homestead, Florida, United States
Site 631
Miami, Florida, United States
Site 658
Miami, Florida, United States
Site 654
Miami, Florida, United States
Site 626
Miami, Florida, United States
Site 637
Miami, Florida, United States
Site 653
Miami, Florida, United States
Site 641
Miami, Florida, United States
Site 645
Miami, Florida, United States
Site 640
Miami Lakes, Florida, United States
Site 662
Miami Lakes, Florida, United States
Site 609
Saint Cloud, Florida, United States
Site 644
Council Bluffs, Iowa, United States
Site 657
Boston, Massachusetts, United States
Site 617
St Louis, Missouri, United States
Site 602
Butte, Montana, United States
Site 623
Las Vegas, Nevada, United States
Site 630
Somers Point, New Jersey, United States
Site 647
Jackson Heights, New York, United States
Site 632
Mount Airy, North Carolina, United States
Site 649
Toledo, Ohio, United States
Site 607
Rapid City, South Dakota, United States
Site 635
Jackson, Tennessee, United States
Site 628
Smyrna, Tennessee, United States
Site 633
Baytown, Texas, United States
Site 605
Channelview, Texas, United States
Site 625
Houston, Texas, United States
Site 627
Houston, Texas, United States
Site 634
Sugar Land, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PTK0796-ABSI-16301
Identifier Type: -
Identifier Source: org_study_id
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