Clinical trial NCT02877927: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Skin Structures and Soft Tissue Infections
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Early Clinical Response
timeFrame: Screening; 48 to 72 hours after the first dose of test article
Secondary outcomes:
measure: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
timeFrame: Screening; 7 to 14 days after the last day of therapy
measure: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population
timeFrame: Screening; 7 to 14 days after the last day of therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 620
state: Alabama
city: Mobile
country: United States
facility: Site 642
state: Alabama
city: Anaheim
country: United States
facility: Site 616
state: California
city: Anaheim
country: United States
facility: Site 601
state: California
city: Bakersfield
country: United States
facility: Site 636
state: California
city: Buena Park
country: United States
facility: Site 606
state: California
city: Chula Vista
country: United States
facility: Site 604
state: California
city: Huntington Beach
country: United States
facility: Site 659
state: California
city: La Mesa
country: United States
facility: Site 608
state: California
city: Laguna Hills
country: United States
facility: Site 618
state: California
city: Long Beach
country: United States
facility: Site 612
state: California
city: Modesto
country: United States
facility: Site 648
state: California
city: Oceanside
country: United States
facility: Site 610
state: California
city: San Diego
country: United States
facility: Site 615
state: California
city: San Diego
country: United States
facility: Site 621
state: California
city: San Francisco
country: United States
facility: Site 613
state: California
city: Stockton
country: United States
facility: Site 603
state: California
city: Torrance
country: United States
facility: Site 650
state: California
city: Ventura
country: United States
facility: Site 646
state: California
city: DeLand
country: United States
facility: Site 614
state: Florida
city: Fort Myers
country: United States
facility: Site 655
state: Florida
city: Homestead
country: United States
facility: Site 656
state: Florida
city: Miami Lakes
country: United States
facility: Site 640
state: Florida
city: Miami Lakes
country: United States
facility: Site 662
state: Florida
city: Miami
country: United States
facility: Site 631
state: Florida
city: Miami
country: United States
facility: Site 658
state: Florida
city: Miami
country: United States
facility: Site 654
state: Florida
city: Miami
country: United States
facility: Site 626
state: Florida
city: Miami
country: United States
facility: Site 637
state: Florida
city: Miami
country: United States
facility: Site 653
state: Florida
city: Miami
country: United States
facility: Site 641
state: Florida
city: Miami
country: United States
facility: Site 645
state: Florida
city: Saint Cloud
country: United States
facility: Site 609
state: Florida
city: Council Bluffs
country: United States
facility: Site 644
state: Iowa
city: Boston
country: United States
facility: Site 657
state: Massachusetts
city: Saint Louis
country: United States
facility: Site 617
state: Missouri
city: Butte
country: United States
facility: Site 602
state: Montana
city: Las Vegas
country: United States
facility: Site 623
state: Nevada
city: Somers Point
country: United States
facility: Site 630
state: New Jersey
city: Jackson Heights
country: United States
facility: Site 647
state: New York
city: Mount Airy
country: United States
facility: Site 632
state: North Carolina
city: Toledo
country: United States
facility: Site 649
state: Ohio
city: Rapid City
country: United States
facility: Site 607
state: South Dakota
city: Jackson
country: United States
facility: Site 635
state: Tennessee
city: Smyrna
country: United States
facility: Site 628
state: Tennessee
city: Baytown
country: United States
facility: Site 633
state: Texas
city: Channelview
country: United States
facility: Site 605
state: Texas
city: Houston
country: United States
facility: Site 625
state: Texas
city: Houston
country: United States
facility: Site 627
state: Texas
city: Sugar Land
country: United States
facility: Site 634
state: Texas
Study officials:
affiliation: Senior Director, Clinical Operations
name: Amy Manley
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.