Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials.

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES Infectious Diseases and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-26 DOI:10.1007/s40121-024-01057-3

George D Rodriguez, Nathan Warren, Roman Yashayev, Surya Chitra, Maria Amodio-Groton, Kelly Wright

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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.

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静脉注射与口服奥马大环素或利奈唑胺治疗急性皮肤细菌感染：OASIS 试验的事后分析。

简介：治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）的适当口服抗生素疗法是一项挑战，因为目前的口服治疗指南并未完全涵盖最常见的皮肤病原体。利奈唑胺和奥马他环素都有静脉注射或生物等效口服制剂：本研究对 OASIS-1（ClinicalTrials.gov 标识符 NCT02378480）和 OASIS-2（ClinicalTrials.gov 标识符 NCT02877927）三期试验进行了事后分析，评估了使用奥马大环素或利奈唑胺治疗 ABSSSI 患者的静脉注射疗法与口服疗法的安全性和临床疗效。在OASIS-1中，患者随机接受静脉注射奥马大环素或利奈唑胺治疗，并可选择转为口服治疗；而在OASIS-2中，患者接受口服奥马大环素或利奈唑胺治疗。两项研究的治疗时间均为 7-14 天。主要终点是48至72小时的早期临床反应（ECR），定义为存活和病灶面积缩小≥20%，且无需抗菌治疗：共评估了645名静脉注射起始的住院患者和735名口服药物起始的门诊患者。静脉注射起始组的中位年龄为 47 岁，口服起始组的中位年龄为 44 岁。大多数患者仅有革兰氏阳性感染（两组均为 97%；ECR [85.2% IV-start 组和 85.0% PO-start 组]），两组的治疗突发不良事件（AEs）发生率相似。最常见的不良反应是恶心（11.2%[静脉注射起始]与18.9%[口服起始]）和皮下脓肿（5.6%[静脉注射起始]与1.9%[口服起始]）。两组中因AE而停药的情况都不常见（2%[静脉注射起始]对1.2%[口服起始]）：结论：在使用奥美沙星或利奈唑胺治疗ABSSSIs时，口服疗法与静脉疗法具有同等疗效。这些数据加强了口服奥马大环素作为 ABSSSI 治疗选择的证据，特别是对于那些因其他疗法的局限性而治疗失败的患者：试验注册：Clinicaltrials.gov，NCT02378480 和 NCT02877927。

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来源期刊

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.