Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus

SOLO I, SOLO II Investigators

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The phase 3 studies SOLO I and SOLO II demonstrated comparable efficacy and safety of a single dose of oritavancin compared with 7–10 days of twice-daily vancomycin in adults with acute bacterial skin and skin-structure infections (ABSSSIs). The present analysis assessed clinical responses by pathogen at 48–72 h and at study days 14–24 in SOLO patients within the pooled data set. Of the 1959 patients in the pooled SOLO studies, 1067 had at least one baseline Gram-positive pathogen and 405 had MRSA. Clinical response rates were similar for oritavancin- and vancomycin-treated patients by pathogen, including Staphylococcus aureus with or without the Panton–Valentine leukocidin (pvl) gene and from different clonal complexes, and were similar for pathogens within each treatment group. Oritavancin exhibited potent in vitro activity against all baseline pathogens, with MIC90 values (minimum inhibitory concentration required to inhibit 90% of the isolates) of 0.12 µg/mL for Staphylococcus  aureus, 0.25 µg/mL for Streptococcus pyogenes and 0.06 µg/mL for Enterococcus faecalis. Whereas both oritavancin and vancomycin achieved similarly high rates of clinical response by pathogen, including methicillin-susceptible and -resistant Staphylococcus aureus, oritavancin provides a single-dose alternative to 7–10 days of twice-daily vancomycin to treat ABSSSIs.

Original languageEnglish (US)
Pages (from-to)528-534
Number of pages7
JournalInternational journal of antimicrobial agents
Volume48
Issue number5
DOIs
StatePublished - Nov 1 2016

Fingerprint

oritavancin
Methicillin-Resistant Staphylococcus aureus
Vancomycin
Skin
Infection
Staphylococcus aureus
Therapeutics
Leukocidins
Enterococcus faecalis
Streptococcus pyogenes
Microbial Sensitivity Tests
Anti-Bacterial Agents
Safety

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases
  • Pharmacology (medical)

Keywords

  • Acute bacterial skin infection
  • Clinical efficacy
  • Lipoglycopeptide
  • MRSA
  • Phase 3 study
  • Single-dose treatment

Cite this

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title = "Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus",
abstract = "Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The phase 3 studies SOLO I and SOLO II demonstrated comparable efficacy and safety of a single dose of oritavancin compared with 7–10 days of twice-daily vancomycin in adults with acute bacterial skin and skin-structure infections (ABSSSIs). The present analysis assessed clinical responses by pathogen at 48–72 h and at study days 14–24 in SOLO patients within the pooled data set. Of the 1959 patients in the pooled SOLO studies, 1067 had at least one baseline Gram-positive pathogen and 405 had MRSA. Clinical response rates were similar for oritavancin- and vancomycin-treated patients by pathogen, including Staphylococcus aureus with or without the Panton–Valentine leukocidin (pvl) gene and from different clonal complexes, and were similar for pathogens within each treatment group. Oritavancin exhibited potent in vitro activity against all baseline pathogens, with MIC90 values (minimum inhibitory concentration required to inhibit 90{\%} of the isolates) of 0.12 µg/mL for Staphylococcus  aureus, 0.25 µg/mL for Streptococcus pyogenes and 0.06 µg/mL for Enterococcus faecalis. Whereas both oritavancin and vancomycin achieved similarly high rates of clinical response by pathogen, including methicillin-susceptible and -resistant Staphylococcus aureus, oritavancin provides a single-dose alternative to 7–10 days of twice-daily vancomycin to treat ABSSSIs.",
keywords = "Acute bacterial skin infection, Clinical efficacy, Lipoglycopeptide, MRSA, Phase 3 study, Single-dose treatment",
author = "{SOLO I, SOLO II Investigators} and Corey, {G. Ralph} and Arhin, {Francis F.} and Wikler, {Matthew A.} and Sahm, {Daniel F.} and Kreiswirth, {Barry N.} and Mediavilla, {Jos{\'e} R.} and Samantha Good and Claude Fiset and Hai Jiang and Greg Moeck and Heidi Kabler and Sinikka Green and William O'Riordan",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.ijantimicag.2016.07.019",
language = "English (US)",
volume = "48",
pages = "528--534",
journal = "International Journal of Antimicrobial Agents",
issn = "0924-8579",
publisher = "Elsevier",
number = "5",

}

TY - JOUR

T1 - Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus

AU - SOLO I, SOLO II Investigators

AU - Corey, G. Ralph

AU - Arhin, Francis F.

AU - Wikler, Matthew A.

AU - Sahm, Daniel F.

AU - Kreiswirth, Barry N.

AU - Mediavilla, José R.

AU - Good, Samantha

AU - Fiset, Claude

AU - Jiang, Hai

AU - Moeck, Greg

AU - Kabler, Heidi

AU - Green, Sinikka

AU - O'Riordan, William

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The phase 3 studies SOLO I and SOLO II demonstrated comparable efficacy and safety of a single dose of oritavancin compared with 7–10 days of twice-daily vancomycin in adults with acute bacterial skin and skin-structure infections (ABSSSIs). The present analysis assessed clinical responses by pathogen at 48–72 h and at study days 14–24 in SOLO patients within the pooled data set. Of the 1959 patients in the pooled SOLO studies, 1067 had at least one baseline Gram-positive pathogen and 405 had MRSA. Clinical response rates were similar for oritavancin- and vancomycin-treated patients by pathogen, including Staphylococcus aureus with or without the Panton–Valentine leukocidin (pvl) gene and from different clonal complexes, and were similar for pathogens within each treatment group. Oritavancin exhibited potent in vitro activity against all baseline pathogens, with MIC90 values (minimum inhibitory concentration required to inhibit 90% of the isolates) of 0.12 µg/mL for Staphylococcus  aureus, 0.25 µg/mL for Streptococcus pyogenes and 0.06 µg/mL for Enterococcus faecalis. Whereas both oritavancin and vancomycin achieved similarly high rates of clinical response by pathogen, including methicillin-susceptible and -resistant Staphylococcus aureus, oritavancin provides a single-dose alternative to 7–10 days of twice-daily vancomycin to treat ABSSSIs.

AB - Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The phase 3 studies SOLO I and SOLO II demonstrated comparable efficacy and safety of a single dose of oritavancin compared with 7–10 days of twice-daily vancomycin in adults with acute bacterial skin and skin-structure infections (ABSSSIs). The present analysis assessed clinical responses by pathogen at 48–72 h and at study days 14–24 in SOLO patients within the pooled data set. Of the 1959 patients in the pooled SOLO studies, 1067 had at least one baseline Gram-positive pathogen and 405 had MRSA. Clinical response rates were similar for oritavancin- and vancomycin-treated patients by pathogen, including Staphylococcus aureus with or without the Panton–Valentine leukocidin (pvl) gene and from different clonal complexes, and were similar for pathogens within each treatment group. Oritavancin exhibited potent in vitro activity against all baseline pathogens, with MIC90 values (minimum inhibitory concentration required to inhibit 90% of the isolates) of 0.12 µg/mL for Staphylococcus  aureus, 0.25 µg/mL for Streptococcus pyogenes and 0.06 µg/mL for Enterococcus faecalis. Whereas both oritavancin and vancomycin achieved similarly high rates of clinical response by pathogen, including methicillin-susceptible and -resistant Staphylococcus aureus, oritavancin provides a single-dose alternative to 7–10 days of twice-daily vancomycin to treat ABSSSIs.

KW - Acute bacterial skin infection

KW - Clinical efficacy

KW - Lipoglycopeptide

KW - MRSA

KW - Phase 3 study

KW - Single-dose treatment

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U2 - 10.1016/j.ijantimicag.2016.07.019

DO - 10.1016/j.ijantimicag.2016.07.019

M3 - Article

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AN - SCOPUS:84994049259

VL - 48

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EP - 534

JO - International Journal of Antimicrobial Agents

JF - International Journal of Antimicrobial Agents

SN - 0924-8579

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