Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
- Conditions
- Bacterial InfectionsSkin Structures and Soft Tissue Infections
- Interventions
- Registration Number
- NCT02877927
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 735
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omadacycline Omadacycline Omadacycline tablets Linezolid Linezolid Linezolid tablets
- Primary Outcome Measures
Name Time Method Number of Participants With Early Clinical Response 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
Name Time Method 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 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 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; 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.
Trial Locations
- Locations (50)
Site 620
🇺🇸Birmingham, Alabama, United States
Site 606
🇺🇸Buena Park, California, United States
Site 604
🇺🇸Chula Vista, California, United States
Site 608
🇺🇸La Mesa, California, United States
Site 659
🇺🇸Huntington Beach, 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 603
🇺🇸Stockton, California, United States
Site 613
🇺🇸San Francisco, California, United States
Site 656
🇺🇸Homestead, Florida, United States
Site 646
🇺🇸Ventura, California, United States
Site 614
🇺🇸DeLand, Florida, United States
Site 641
🇺🇸Miami, Florida, United States
Site 609
🇺🇸Saint Cloud, Florida, United States
Site 644
🇺🇸Council Bluffs, Iowa, United States
Site 617
🇺🇸Saint Louis, Missouri, 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 633
🇺🇸Baytown, Texas, United States
Site 605
🇺🇸Channelview, Texas, United States
Site 625
🇺🇸Houston, Texas, 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 618
🇺🇸Laguna Hills, California, United States
Site 655
🇺🇸Fort Myers, Florida, United States
Site 650
🇺🇸Torrance, California, United States
Site 657
🇺🇸Boston, Massachusetts, United States
Site 640
🇺🇸Miami Lakes, Florida, United States
Site 631
🇺🇸Miami, Florida, United States
Site 658
🇺🇸Miami, Florida, United States
Site 654
🇺🇸Miami, Florida, United States
Site 637
🇺🇸Miami, Florida, United States
Site 662
🇺🇸Miami Lakes, Florida, United States
Site 627
🇺🇸Houston, Texas, United States
Site 634
🇺🇸Sugar Land, Texas, United States
Site 626
🇺🇸Miami, Florida, United States
Site 653
🇺🇸Miami, Florida, United States
Site 645
🇺🇸Miami, Florida, United States
Site 602
🇺🇸Butte, Montana, United States
Site 623
🇺🇸Las Vegas, Nevada, United States
Site 630
🇺🇸Somers Point, New Jersey, United States
Site 607
🇺🇸Rapid City, South Dakota, United States
Site 635
🇺🇸Jackson, Tennessee, United States
Site 621
🇺🇸San Diego, California, United States
Site 628
🇺🇸Smyrna, Tennessee, United States