PMID- 29977954
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 5
IP  - 6
DP  - 2018 Jun
TI  - A Real-world Patient Registry for Oritavancin Demonstrates Efficacy and Safety 
      Consistent With the Phase 3 SOLO Program.
PG  - ofy051
LID - 10.1093/ofid/ofy051 [doi]
LID - ofy051
AB  - BACKGROUND: Oritavancin is a lipoglycopeptide used in the treatment of acute 
      bacterial skin and skin structure infections (ABSSSIs) in adults. To characterize 
      its use in patients in the postapproval setting, a patient registry was 
      developed. METHODS: Data collected in an ongoing retrospective observational 
      registry are used to evaluate the utilization, outcomes, and adverse events (AEs) 
      associated with oritavancin for the treatment of infections presumed or confirmed 
      to be caused by gram-positive (GP) bacteria in clinical practice. RESULTS: Data 
      for 112 patients from 8 sites were collected. All patients received a single 
      1200-mg dose of oritavancin mostly in an infusion center. Infection type included 
      cellulitis (67.0%), cutaneous abscess (21.4%), and wound (4.5%). Most patients 
      (72.3%) received 1 or more antimicrobial agents for the index GP infection within 
      28 days prior to oritavancin treatment. Of positive cultures obtained prior to 
      oritavancin administration, methicillin-resistant Staphylococcus aureus was the 
      predominant pathogen (78.4%). A positive clinical response was observed in 92.8% 
      of patients, and microbial eradication was observed in 90.0% of patients with 
      post-therapy cultures. Within 28 days following oritavancin administration, 4 
      (3.6%) patients were hospitalized for failure of treatment of the index 
      infection. Five (4.5%) patients experienced 1 or more possible drug-related AEs, 
      which were consistent with types previously reported. There were no drug-related 
      serious AEs reported. CONCLUSIONS: Clinical and microbiologic outcomes and safety 
      of single-dose oritavancin 1200 mg were similar in this older patient population 
      with multiple comorbid conditions to those observed in the phase 3 SOLO trials.
FAU - Redell, Mark
AU  - Redell M
AD  - The Medicines Company, Parsippany, New Jersey.
FAU - Moeck, Greg
AU  - Moeck G
AD  - The Medicines Company, St. Laurent, Quebec, Canada.
FAU - Lucasti, Christopher
AU  - Lucasti C
AD  - South Jersey Infectious Diseases, Somers Point, New Jersey.
FAU - Durso, Stephanie
AU  - Durso S
AD  - The Medicines Company, San Diego, California.
FAU - Kennedy, Cynthia
AU  - Kennedy C
AD  - The Medicines Company, Parsippany, New Jersey.
FAU - Fusaro, Karen
AU  - Fusaro K
AD  - The Medicines Company, Parsippany, New Jersey.
FAU - Loutit, Jeff
AU  - Loutit J
AD  - The Medicines Company, San Diego, California.
FAU - Dudley, Michael
AU  - Dudley M
AD  - The Medicines Company, San Diego, California.
LA  - eng
PT  - Journal Article
DEP - 20180319
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC6016411
OTO - NOTNLM
OT  - ABSSSI
OT  - oritavancin
OT  - registry
OT  - skin infections
EDAT- 2018/07/07 06:00
MHDA- 2018/07/07 06:01
PMCR- 2018/03/19
CRDT- 2018/07/07 06:00
PHST- 2017/11/01 00:00 [received]
PHST- 2018/03/16 00:00 [accepted]
PHST- 2018/07/07 06:00 [entrez]
PHST- 2018/07/07 06:00 [pubmed]
PHST- 2018/07/07 06:01 [medline]
PHST- 2018/03/19 00:00 [pmc-release]
AID - ofy051 [pii]
AID - 10.1093/ofid/ofy051 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2018 Mar 19;5(6):ofy051. doi: 10.1093/ofid/ofy051. 
      eCollection 2018 Jun.