PMID- 35015255
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 11
IP  - 1
DP  - 2022 Feb
TI  - Efficacy and Safety of Omadacycline Versus Linezolid in Acute Bacterial Skin and 
      Skin Structure Infections in Persons Who Inject Drugs.
PG  - 517-531
LID - 10.1007/s40121-021-00587-4 [doi]
AB  - INTRODUCTION: Acute bacterial skin and skin structure infections (ABSSSI) 
      represent one of the most common reasons for emergency department visits, and are 
      frequent complications of intravenous drug use in persons who inject drugs 
      (PWID). This study examined the efficacy and safety of omadacycline, versus 
      linezolid, in PWID and persons who do not inject drugs, in the Phase 3 
      Omadacycline in Acute Skin and Skin Structure Infection (OASIS-1, OASIS-2) 
      studies. METHODS: Eligible participants were aged >/= 18 years with qualifying skin 
      infections: wound infection, cellulitis, erysipelas, or major abscess. The 
      primary efficacy endpoint was early clinical response (ECR) in the modified 
      intent-to-treat (mITT) population, defined as survival with >/= 20% reduction in 
      lesion size at 48-72 h after the first dose of omadacycline or linezolid. Key 
      secondary endpoints included investigator-assessed clinical response at the 
      post-treatment evaluation (PTE) in the mITT and clinical per-protocol 
      populations, and clinical response at PTE in the micro-mITT population. Safety 
      was assessed based on adverse events (AEs) and standard clinical laboratory 
      tests. Efficacy endpoints of clinical response at ECR and PTE were analyzed for 
      the mITT and clinically evaluable (CE) PTE populations. RESULTS: In total, 1380 
      patients (822 PWID, 558 non-PWID) were included in this secondary analysis. Wound 
      infections were reported more frequently in the PWID subgroup (72.8%) at 
      baseline; cellulitis or erysipelas (43.9%) and major abscess (37.4%) were the 
      most frequently reported baseline infections in the non-PWID subgroup. Clinical 
      success rates at ECR and PTE in the mITT population, and at PTE in the CE 
      population, were high for patients receiving omadacycline or linezolid. Severe or 
      serious treatment-emergent AEs (TEAEs), and TEAEs leading to discontinuation, 
      were infrequent. CONCLUSION: This subgroup analysis showed that omadacycline was 
      effective and well tolerated, regardless of PWID status.
CI  - (c) 2022. The Author(s).
FAU - Moran, Gregory J
AU  - Moran GJ
AD  - Olive View-UCLA Medical Center, 14445 Olive View Dr, Sylmar, CA, 91342, USA. 
      gmoran@ucla.edu.
FAU - Chitra, Surya
AU  - Chitra S
AD  - Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
FAU - McGovern, Paul C
AU  - McGovern PC
AD  - Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
LA  - eng
PT  - Journal Article
DEP - 20220111
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC8847501
OTO - NOTNLM
OT  - Abscess
OT  - Cellulitis
OT  - Drug use
OT  - Erysipelas
OT  - Infectious disease
OT  - Intravenous drug use
OT  - Wounds
EDAT- 2022/01/12 06:00
MHDA- 2022/01/12 06:01
PMCR- 2022/01/11
CRDT- 2022/01/11 12:34
PHST- 2021/11/16 00:00 [received]
PHST- 2021/12/23 00:00 [accepted]
PHST- 2022/01/12 06:00 [pubmed]
PHST- 2022/01/12 06:01 [medline]
PHST- 2022/01/11 12:34 [entrez]
PHST- 2022/01/11 00:00 [pmc-release]
AID - 10.1007/s40121-021-00587-4 [pii]
AID - 587 [pii]
AID - 10.1007/s40121-021-00587-4 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2022 Feb;11(1):517-531. doi: 10.1007/s40121-021-00587-4. Epub 
      2022 Jan 11.