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Outpatient treatment of acute bacterial skin and skin structure infections (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States: Subgroup analysis of 2 randomized phase 3 trials.

Abstract Acute bacterial skin and skin structure infections (ABSSSI) are a frequent cause of hospital admissions in the United States. Safe and effective outpatient treatments may lower ABSSSI-associated health care costs by reducing unnecessary hospital admissions. Using data from 2 phase 3 trials (ESTABLISH-1, NCT01170221; ESTABLISH-2, NCT01421511), this post-hoc analysis explored the efficacy and safety of tedizolid in an outpatient setting.
PMID
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Authors

Mayor MeshTerms

Ambulatory Care

Keywords
Journal Title medicine
Publication Year Start




PMID- 29384903
OWN - NLM
STAT- MEDLINE
DCOM- 20180209
LR  - 20180220
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 96
IP  - 52
DP  - 2017 Dec
TI  - Outpatient treatment of acute bacterial skin and skin structure infections
      (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States:
      Subgroup analysis of 2 randomized phase 3 trials.
PG  - e9163
LID - 10.1097/MD.0000000000009163 [doi]
AB  - BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSI) are a
      frequent cause of hospital admissions in the United States. Safe and effective
      outpatient treatments may lower ABSSSI-associated health care costs by reducing
      unnecessary hospital admissions. Using data from 2 phase 3 trials (ESTABLISH-1,
      NCT01170221; ESTABLISH-2, NCT01421511), this post-hoc analysis explored the
      efficacy and safety of tedizolid in an outpatient setting. METHODS: Subgroup
      analysis was performed on US outpatients (defined as patients who were not in
      hospital at the time of treatment initiation) with ABSSSI caused by presumed or
      proven gram-positive pathogens. Patients were randomly assigned to receive
      tedizolid phosphate 200 mg once daily for 6 days (n = 403) or linezolid 600 mg
      twice daily for 10 days (n = 410). The primary end point was early clinical
      response (48-72 hours after the start of treatment). Secondary end points
      included investigator-assessed clinical response at end of therapy (EOT) and
      post-therapy evaluation (PTE; 7-14 days after therapy). Additional assessments
      included the patient-reported level of pain using a visual analog scale (VAS) and
      the per-pathogen favorable microbiological response rate at the PTE visit.
      Compliance with treatment and safety outcomes was also recorded. RESULTS: Early
      clinical response was similar between treatment groups (tedizolid, 82.4%;
      linezolid, 79.0%), as was investigator-assessed clinical response at EOT
      (tedizolid, 87.1%; linezolid, 86.1%) and PTE (tedizolid, 83.1%; linezolid,
      83.7%). Mean changes from baseline to days 10 to 13 in VAS scores were identical 
      between treatment groups (tedizolid, -51.9 mm; linezolid, -51.9 mm).
      Microbiological eradication rates were generally similar in both treatment groups
      for all key pathogens. Patients in both groups had favorable response at PTE.
      More tedizolid-treated patients (89.3%) than linezolid-treated patients (77.3%)
      were compliant with treatment. The most frequently reported drug-related
      treatment-emergent adverse events were nausea (tedizolid, 10.7%; linezolid,
      13.8%), diarrhea (tedizolid, 4.5%; linezolid, 5.9%), and headache (tedizolid,
      5.5%; linezolid, 4.4%). Treatment discontinuation rates were low for both
      treatment groups (tedizolid, 0.7%; linezolid, 1.0%). CONCLUSION: Short-course
      therapy with tedizolid can successfully treat patients with ABSSSI caused by
      presumed or proven gram-positive pathogens in an outpatient setting.
CI  - Copyright (c) 2017 The Authors. Published by Wolters Kluwer Health, Inc. All
      rights reserved.
FAU - De Anda, Carisa
AU  - De Anda C
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Anuskiewicz, Steven
AU  - Anuskiewicz S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Prokocimer, Philippe
AU  - Prokocimer P
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Vazquez, Jose
AU  - Vazquez J
AD  - Medical College of Georgia, Augusta University, Augusta, GA, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Organophosphates)
RN  - 0 (Oxazoles)
RN  - ISQ9I6J12J (Linezolid)
RN  - O7DRJ6R4DW (torezolid phosphate)
SB  - AIM
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Ambulatory Care
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Female
MH  - Humans
MH  - Linezolid/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Organophosphates/*therapeutic use
MH  - Oxazoles/*therapeutic use
MH  - Skin Diseases, Bacterial/*drug therapy/pathology
MH  - Treatment Outcome
MH  - United States
MH  - Young Adult
EDAT- 2018/02/01 06:00
MHDA- 2018/02/10 06:00
CRDT- 2018/02/01 06:00
PHST- 2018/02/01 06:00 [entrez]
PHST- 2018/02/01 06:00 [pubmed]
PHST- 2018/02/10 06:00 [medline]
AID - 10.1097/MD.0000000000009163 [doi]
AID - 00005792-201712290-00011 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2017 Dec;96(52):e9163. doi: 10.1097/MD.0000000000009163.