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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.
Moran, Gregory J; De Anda, Carisa; Das, Anita F; Green, Sinikka; Mehra, Purvi; Prokocimer, Philippe.
Afiliação
  • Moran GJ; Division of Infectious Diseases, Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.
  • De Anda C; MRL, Merck & Co., Inc., Kenilworth, NJ, USA. carisa.de.anda@merck.com.
  • Das AF; Department of Biostatistics, InClin, San Mateo, CA, USA.
  • Green S; eStudySite, San Diego, CA, USA.
  • Mehra P; Artemis Institute for Clinical Research, San Diego, CA, USA.
  • Prokocimer P; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Infect Dis Ther ; 7(4): 509-522, 2018 Dec.
Article em En | MEDLINE | ID: mdl-30242736
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.
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Ano de publicação: 2018 Tipo de documento: Article