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
| Autor: | Philippe Prokocimer, Gregory J. Moran, Carisa De Anda, Sinikka Green, Anita Das, Purvi Mehra |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Microbiology (medical) medicine.medical_specialty 030106 microbiology Erysipelas law.invention lcsh:Infectious and parasitic diseases 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine mental disorders Clinical endpoint medicine lcsh:RC109-216 030212 general & internal medicine Adverse effect Original Research business.industry Linezolid virus diseases ABSSSI medicine.disease Clinical trial Infectious Diseases chemistry Cellulitis Injection drug user Tedizolid business |
| Zdroj: | Infectious Diseases and Therapy Infectious Diseases and Therapy, Vol 7, Iss 4, Pp 509-522 (2018) |
| ISSN: | 2193-8229 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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