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Omadacycline for Acute Bacterial Skin and Skin-Structure Infections.

William O'Riordan1, Sinikka Green1, J Scott Overcash1

  • 1From eStudySite, San Diego (W.O., J.S.O.), and AD Stats Consulting, Guerneville (A.F.D.) - both in California; First Choice Emergency Room, Austin, TX (S.G.); University Hospital for Infectious Diseases "Dr. F. Mihaljević," Zagreb, Croatia (I.P.); AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece (S.M.); Riga Stradins University, Paula Stradins Clinical Hospital, Riga, Latvia (J.G.); and Paratek Pharmaceuticals, King of Prussia, PA (L.G.-R., E.T., P.B.E., A.M., S.A.V., J.N.S., E.L.).

The New England Journal of Medicine
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Omadacycline demonstrated noninferiority to linezolid in treating acute bacterial skin infections. Both antibiotics showed similar efficacy and safety profiles in this clinical trial.

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Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Clinical Trials

Background:

  • Acute bacterial skin and skin-structure infections (ABSSSI) cause significant morbidity and healthcare costs.
  • Omadacycline, an aminomethylcycline antibiotic, exhibits activity against common ABSSSI pathogens, including resistant strains.
  • Omadacycline offers flexible oral or intravenous administration and once-daily dosing.

Purpose of the Study:

  • To evaluate the noninferiority of omadacycline compared to linezolid for ABSSSI treatment.
  • To assess the early and post-treatment clinical response rates in patients receiving omadacycline versus linezolid.
  • To compare the safety profiles of omadacycline and linezolid in the treatment of ABSSSI.

Main Methods:

  • A double-blind, randomized trial comparing omadacycline and linezolid in adults with ABSSSI.
  • Patients received intravenous or oral administration of either omadacycline or linezolid for 7–14 days.
  • Primary endpoint: early clinical response at 48–72 hours; Secondary endpoint: post-treatment clinical response.

Main Results:

  • Omadacycline was noninferior to linezolid for early clinical response (84.8% vs. 85.5%) and post-treatment response (86.1% vs. 83.6% in mITT population).
  • Efficacy was comparable between methicillin-susceptible and methicillin-resistant Staphylococcus aureus infections for both drugs.
  • Adverse events were similar, with gastrointestinal issues being most frequent in both treatment groups (18.0% for omadacycline, 15.8% for linezolid).

Conclusions:

  • Omadacycline is a viable alternative to linezolid for treating acute bacterial skin and skin-structure infections.
  • The study confirmed the noninferiority and similar safety profile of omadacycline compared to linezolid.
  • Omadacycline presents a comparable treatment option with a similar safety profile for ABSSSI.