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.
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 MIC90values (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.
Duke University Medical Center, 310 Trent Drive, Box 90519, Durham, NC 27708, USA.
G Ralph
GR
Corey
The Medicines Company, 7170 Rue Frederick-Banting, Saint-Laurent, QC, Canada H4S 2A1.
Francis F
FF
Arhin
The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
Matthew A
MA
Wikler
International Health Management Associates, 2122 Palmer Drive, Schaumburg, IL 60173, USA.
Daniel F
DF
Sahm
Public Health Research Institute, 225 Warren Street, Newark, NJ 07103, USA.
Barry N
BN
Kreiswirth
Public Health Research Institute, 225 Warren Street, Newark, NJ 07103, USA.
José R
JR
Mediavilla
The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
Samantha
S
Good
The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
Claude
C
Fiset
The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
Hai
H
Jiang
The Medicines Company, 7170 Rue Frederick-Banting, Saint-Laurent, QC, Canada H4S 2A1. Electronic address: greg.moeck@themedco.com.
Greg
G
Moeck
Sunrise Hospital and Medical Center, 3186 S. Maryland Pkwy, Las Vegas, NV 89109, USA.
Heidi
H
Kabler
Sharp Grossmont Hospital, 5555 Grossmont Center Drive, La Mesa, CA 91942, USA.
Sinikka
S
Green
Sharp Chula Vista Medical Center, 751 Medical Center Ct., Chula Vista, CA 91911, USA.
William
W
O'Riordan
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006020:Glycopeptides / Q000008:administration & dosage*; D006094:Gram-Positive Bacteria / Q000145:classification / Q000187:drug effects / Q000302:isolation & purification*; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D000077427:Lipoglycopeptides; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult; D014640:Vancomycin / Q000031:analogs & derivatives
D000900:Anti-Bacterial Agents; D006020:Glycopeptides; D000077427:Lipoglycopeptides; C100708:oritavancin; D014640:Vancomycin
Acute bacterial skin infection; Clinical efficacy; Lipoglycopeptide; MRSA; Phase 3 study; Single-dose treatment