Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Completed · Phase 3

Conditions studied: Bacterial Infections, Skin Structures and Soft Tissue Infections

In brief

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.

Key facts

Study ID

NCT02877927

Run by

Paratek Pharmaceuticals Inc

People needed

735

Starts

2016-08-01

Expected to finish

2017-06-06

Last updated by the study team

2018-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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