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.


Background: Within the last decade, methicillin-resistant Staphylococcus aureus (MRSA) has emerged as a frequent cause of purulent skin and soft tissue infections. New therapeutic options are being investigated for these infections.

Methods: We report an integrated analysis of 2 randomized, controlled studies involving omadacycline, a novel aminomethylcycline, and linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Omadacycline in Acute Skin and Skin Structure Infections Study 1 (OASIS-1) initiated patients on intravenous omadacycline or linezolid, with the option to transition to an oral formulation after day 3. OASIS-2 was an oral-only study of omadacycline versus linezolid.

Results: In total, 691 patients received omadacycline and 689 patients received linezolid. Infection types included wound infection in 46.8% of patients, cellulitis/erysipelas in 30.5%, and major abscess in 22.7%. Pathogens were identified in 73.2% of patients. S. aureus was detected in 74.7% and MRSA in 32.4% of patients in whom a pathogen was identified. Omadacycline was noninferior to linezolid using the Food and Drug Administration primary endpoint of early clinical response (86.2% vs 83.9%; difference 2.3, 95% confidence interval -1.5 to 6.2) and using the European Medicines Agency primary endpoint of investigator-assessed clinical response at the posttreatment evaluation. Clinical responses were similar across different infection types and infections caused by different pathogens. Treatment-emergent adverse events, mostly described as mild or moderate, were reported by 51.1% of patients receiving omadacycline and 41.2% of those receiving linezolid.

Conclusions: Omadacycline was effective and safe in ABSSSI.

Clinical trials registration: NCT02378480 and NCT02877927.

Keywords: MRSA; acute bacterial skin and skin structure infections; omadacycline; skin infection; tetracyclines.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease / therapy
  • Administration, Intravenous
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Drug Administration Routes
  • Female
  • Humans
  • Linezolid / therapeutic use
  • Male
  • Methicillin-Resistant Staphylococcus aureus / drug effects
  • Middle Aged
  • Skin / drug effects*
  • Skin / microbiology
  • Skin / pathology
  • Skin Diseases, Bacterial / drug therapy*
  • Soft Tissue Infections / drug therapy*
  • Tetracyclines / administration & dosage
  • Tetracyclines / therapeutic use*
  • Young Adult


  • Anti-Bacterial Agents
  • Tetracyclines
  • omadacycline
  • Linezolid

Associated data