PMID- 30242736
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 7
IP  - 4
DP  - 2018 Dec
TI  - 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.
PG  - 509-522
LID - 10.1007/s40121-018-0211-4 [doi]
AB  - 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.
FAU - Moran, Gregory J
AU  - Moran GJ
AD  - Division of Infectious Diseases, Department of Emergency Medicine, Olive 
      View-UCLA Medical Center, Sylmar, CA, USA.
FAU - De Anda, Carisa
AU  - De Anda C
AD  - MRL, Merck & Co., Inc., Kenilworth, NJ, USA. carisa.de.anda@merck.com.
FAU - Das, Anita F
AU  - Das AF
AD  - Department of Biostatistics, InClin, San Mateo, CA, USA.
FAU - Green, Sinikka
AU  - Green S
AD  - eStudySite, San Diego, CA, USA.
FAU - Mehra, Purvi
AU  - Mehra P
AD  - Artemis Institute for Clinical Research, San Diego, CA, USA.
FAU - Prokocimer, Philippe
AU  - Prokocimer P
AD  - MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20180921
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC6249184
OTO - NOTNLM
OT  - ABSSSI
OT  - Injection drug user
OT  - Linezolid
OT  - Tedizolid
EDAT- 2018/09/23 06:00
MHDA- 2018/09/23 06:01
PMCR- 2018/09/21
CRDT- 2018/09/23 06:00
PHST- 2017/11/20 00:00 [received]
PHST- 2018/09/23 06:00 [pubmed]
PHST- 2018/09/23 06:01 [medline]
PHST- 2018/09/23 06:00 [entrez]
PHST- 2018/09/21 00:00 [pmc-release]
AID - 10.1007/s40121-018-0211-4 [pii]
AID - 211 [pii]
AID - 10.1007/s40121-018-0211-4 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2018 Dec;7(4):509-522. doi: 10.1007/s40121-018-0211-4. Epub 2018 
      Sep 21.