Efficacy and Safety of Tedizolid and Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Injection Drug Users: Analysis of Two Clinical Trials

• Main Authors: Gregory J. Moran, Carisa De Anda, Anita F. Das, Sinikka Green, Purvi Mehra, Philippe Prokocimer
• Format: Article
• Language: English
• Published: Adis, Springer Healthcare 2018-09-01
• Series: Infectious Diseases and Therapy
• Subjects: ABSSSI; Injection drug user; Linezolid; Tedizolid
• Online Access: http://link.springer.com/article/10.1007/s40121-018-0211-4
• ISSN: 2193-8229; 2193-6382

Abstract Introduction Injection drug users (IDUs) often develop acute bacterial skin and skin structure infections (ABSSSI) and use emergency departments as their primary source for medical care. Methods A post hoc subgroup analysis of two randomized trials examined the efficacy and safety of tedizolid in the treatment of ABSSSI in IDUs. IDUs (n = 389) were identified from two pooled phase 3 trials (NCT01170221, NCT01421511) in patients with ABSSSI (n = 1333). Patients were randomly assigned to tedizolid phosphate (200 mg once daily, 6 days) or linezolid (600 mg twice daily, 10 days). Primary endpoint was ≥ 20% reduction in lesion area from baseline at 48 –72 h. Secondary endpoints included investigator-assessed clinical and microbiological response at the post-therapy evaluation (PTE). Results Wound infection was more common in IDUs (52.2%), while cellulitis/erysipelas was more common in non-IDUs (55.9%). Most infections were due to Staphylococcus aureus (IDUs, 75.2%; non-IDUs, 85.6%), while oral pathogens were more prevalent in IDUs. Early clinical success rates for tedizolid and linezolid were 82.5% and 79.6% in IDUs and 81.3% and 79.3% for non-IDUs, respectively; responses at PTE were similar. Microbiological response per pathogen was similar between treatment groups. Rates of treatment-emergent adverse events (AEs) in IDUs were comparable between tedizolid (46.2%) and linezolid (47.8%) arms, while lower incidence of gastrointestinal AEs was observed with tedizolid (20.3%) than with linezolid (25.1%). Conclusion Efficacy and safety of tedizolid and linezolid in the treatment of ABSSSI was similar in IDUs and non-IDUs, supporting the use of oxazolidinones in treating ABSSSIs in IDUs. Funding Merck & Co., Inc., Kenilworth, NJ, USA.