Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials
Abstract Introduction Appropriate oral antibiotic therapy for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is a challenge, as current oral treatment guidelines do not fully cover the most common skin pathogens. Both linezolid and omadacycline are available as intraven...
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Adis, Springer Healthcare
2024-10-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-024-01057-3 |
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| author | George D. Rodriguez Nathan Warren Roman Yashayev Surya Chitra Maria Amodio-Groton Kelly Wright |
| author_facet | George D. Rodriguez Nathan Warren Roman Yashayev Surya Chitra Maria Amodio-Groton Kelly Wright |
| author_sort | George D. Rodriguez |
| collection | DOAJ |
| description | Abstract Introduction Appropriate oral antibiotic therapy for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is a challenge, as current oral treatment guidelines do not fully cover the most common skin pathogens. Both linezolid and omadacycline are available as intravenous or bioequivalent oral formulations. Materials and methods This post hoc analysis of the OASIS-1 (ClinicalTrials.gov identifier NCT02378480) and OASIS-2 (ClinicalTrials.gov identifier NCT02877927) phase 3 trials assessed safety and clinical efficacy of intravenous (IV)-start versus oral (PO)-start therapy in patients treated with omadacycline or linezolid for ABSSSI. In OASIS-1, patients were randomized to IV omadacycline or linezolid, with optional switch to oral therapy, while patients in OASIS-2 received oral omadacycline or linezolid. Treatment was provided for 7–14 days in both studies. The primary endpoint was an early clinical response (ECR) at 48 to 72 h, defined as survival and ≥ 20% reduction in lesion size, without rescue antibacterial therapy. Results A total of 645 IV-start inpatients and 735 PO-start outpatients were assessed. Median age was 47 years for the IV-start group and 44 years for the PO-start group. Most patients had solely gram-positive infections (97% in each group; ECR [85.2% IV-start and 85.0% PO-start]), and the incidence of treatment-emergent adverse events (AEs) was similar between the groups. The most frequent AEs observed were nausea (11.2% [IV-start] versus 18.9% [PO-start]) and subcutaneous abscess (5.6% [IV-start] versus 1.9% [PO-start]). Discontinuation due to AEs was infrequent in both groups (2% [IV-start] versus 1.2% [PO-start]). Conclusion Oral therapy is equally efficacious to IV therapy when omadacycline or linezolid is used to treat ABSSSIs. These data strengthen the evidence for oral omadacycline as a therapeutic option for ABSSSI, particularly for patients who have experienced treatment failure because of the limitations of other therapies. Trial registration Clinicaltrials.gov, NCT02378480 and NCT02877927. |
| format | Article |
| id | doaj-art-eafad45c321d40b98f025298c7cc9a0b |
| institution | OA Journals |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Adis, Springer Healthcare |
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| series | Infectious Diseases and Therapy |
| spelling | doaj-art-eafad45c321d40b98f025298c7cc9a0b2025-08-20T02:33:02ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822024-10-0113122637264810.1007/s40121-024-01057-3Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS TrialsGeorge D. Rodriguez0Nathan Warren1Roman Yashayev2Surya Chitra3Maria Amodio-Groton4Kelly Wright5Division of Antimicrobial Stewardship, New York-Presbyterian QueensDivision of Antimicrobial Stewardship, New York-Presbyterian QueensDivision of Antimicrobial Stewardship, New York-Presbyterian QueensParatek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc.Abstract Introduction Appropriate oral antibiotic therapy for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is a challenge, as current oral treatment guidelines do not fully cover the most common skin pathogens. Both linezolid and omadacycline are available as intravenous or bioequivalent oral formulations. Materials and methods This post hoc analysis of the OASIS-1 (ClinicalTrials.gov identifier NCT02378480) and OASIS-2 (ClinicalTrials.gov identifier NCT02877927) phase 3 trials assessed safety and clinical efficacy of intravenous (IV)-start versus oral (PO)-start therapy in patients treated with omadacycline or linezolid for ABSSSI. In OASIS-1, patients were randomized to IV omadacycline or linezolid, with optional switch to oral therapy, while patients in OASIS-2 received oral omadacycline or linezolid. Treatment was provided for 7–14 days in both studies. The primary endpoint was an early clinical response (ECR) at 48 to 72 h, defined as survival and ≥ 20% reduction in lesion size, without rescue antibacterial therapy. Results A total of 645 IV-start inpatients and 735 PO-start outpatients were assessed. Median age was 47 years for the IV-start group and 44 years for the PO-start group. Most patients had solely gram-positive infections (97% in each group; ECR [85.2% IV-start and 85.0% PO-start]), and the incidence of treatment-emergent adverse events (AEs) was similar between the groups. The most frequent AEs observed were nausea (11.2% [IV-start] versus 18.9% [PO-start]) and subcutaneous abscess (5.6% [IV-start] versus 1.9% [PO-start]). Discontinuation due to AEs was infrequent in both groups (2% [IV-start] versus 1.2% [PO-start]). Conclusion Oral therapy is equally efficacious to IV therapy when omadacycline or linezolid is used to treat ABSSSIs. These data strengthen the evidence for oral omadacycline as a therapeutic option for ABSSSI, particularly for patients who have experienced treatment failure because of the limitations of other therapies. Trial registration Clinicaltrials.gov, NCT02378480 and NCT02877927.https://doi.org/10.1007/s40121-024-01057-3Acute bacterial skin and skin structure infectionsMRSAMethicillin-resistant Staphylococcus aureusOmadacyclineOral antibioticsSkin infections |
| spellingShingle | George D. Rodriguez Nathan Warren Roman Yashayev Surya Chitra Maria Amodio-Groton Kelly Wright Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials Infectious Diseases and Therapy Acute bacterial skin and skin structure infections MRSA Methicillin-resistant Staphylococcus aureus Omadacycline Oral antibiotics Skin infections |
| title | Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials |
| title_full | Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials |
| title_fullStr | Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials |
| title_full_unstemmed | Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials |
| title_short | Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials |
| title_sort | intravenous versus oral omadacycline or linezolid for acute bacterial skin and skin infections a post hoc analysis of the oasis trials |
| topic | Acute bacterial skin and skin structure infections MRSA Methicillin-resistant Staphylococcus aureus Omadacycline Oral antibiotics Skin infections |
| url | https://doi.org/10.1007/s40121-024-01057-3 |
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