Omadacycline for Acute Bacterial Skin and Skin Structure Infections
| Autor: | Evan Tzanis, Amy Manley, Paul C. McGovern, George Sakoulas, Paul B. Eckburg, Judith N. Steenbergen, Fredrick M. Abrahamian, Anita Das |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Adult Male Methicillin-Resistant Staphylococcus aureus medicine.medical_specialty Adolescent 030106 microbiology Administration Oral Supplement Articles MRSA Skin infection medicine.disease_cause Erysipelas 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine Omadacycline medicine Humans 030212 general & internal medicine Adverse effect Aged Skin Aged 80 and over skin infection business.industry Drug Administration Routes Soft Tissue Infections Linezolid omadacycline Skin Diseases Bacterial tetracyclines Middle Aged medicine.disease Methicillin-resistant Staphylococcus aureus acute bacterial skin and skin structure infections Anti-Bacterial Agents Infectious Diseases chemistry Staphylococcus aureus Cellulitis Acute Disease Administration Intravenous Female business |
| Zdroj: | Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America |
| ISSN: | 1537-6591 1058-4838 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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