Single-Dose oritavancin in the treatment of acute bacterial skin infections

New England Journal of Medicine

Volumn 370, Issue 23, 2014, Pages 2180-2190

  Corey, G Ralph ^a   Kabler, Heidi ^b   Mehra, Purvi ^c   Gupta, Sandeep ^e   Overcash, J Scott ^d   Porwal, Ashwin ^f   Giordano, Philip ^g   Lucasti, Christopher ^h   Perez, Antonio ⁱ   Good, Samantha ⁱ   Jiang, Hai ⁱ   Moeck, Greg ⁱ   O'Riordan, William ^c  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b SUNRISE HOSPITAL AND MEDICAL CENTER   (United States)

^c SHARP HEALTHCARE   (United States)

^d SHARP GROSSMONT HOSPITAL   (United States)

^e MV Hospital and Research Center   (India)

^f Inamdar Multispecialty Hospital   (India)

^g ORLANDO HEALTH   (United States)

^h South Jersey Infectious Disease   (United States)

ⁱ MEDICINES COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; ORITAVANCIN; VANCOMYCIN;

ABSCESS; ADULT; AGED; ARTICLE; BACTERIAL SKIN DISEASE; CELLULITIS; CHILD; CHILL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; ENTEROCOCCUS FAECALIS; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPERSENSITIVITY; INFUSION RELATED REACTION; INJECTION SITE EXTRAVASATION; INJECTION SITE PHLEBITIS; INSOMNIA; LIMB ABSCESS; LIMB DISEASE; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SEPSIS; SINGLE DRUG DOSE; SKIN ABSCESS; STREPTOCOCCUS; UNSPECIFIED SIDE EFFECT; URTICARIA; VOMITING; WOUND INFECTION;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLYCOPEPTIDES; HUMANS; INFUSIONS, INTRAVENOUS; INTENTION TO TREAT ANALYSIS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MIDDLE AGED; NAUSEA; SKIN DISEASES, BACTERIAL; VANCOMYCIN; YOUNG ADULT;

EID: 84901790953     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1310422     Document Type: Article

References (36)

1. Landrum ML, Neumann C, Cook C, et al. Epidemiology of Staphylococcus aureus blood and skin and soft tissue infections in the US military health system, 2005-2010. JAMA 2012;308:50-9.
2. Jenkins TC, Sabel AL, Sarcone EE, Price CS, Mehler PS, Burman WJ. Skin and soft-tissue infections requiring hospitalization at an academic medical center: opportunities for antimicrobial stewardship. Clin Infect Dis 2010;51:895-903.
3. Lee BY, Singh A, David MZ, et al. The economic burden of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). Clin Microbiol Infect 2013;19:528-36.
4. Garau J, Ostermann H, Medina J, Avila M, McBride K, Blasi F. Current management of patients hospitalized with complicated skin and soft tissue infections across Europe (2010-2011): assessment of clinical practice patterns and real-life effectiveness of antibiotics from the REACH study. Clin Microbiol Infect 2013;19(9):E377-E785.
5. Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis 2005;41:1373-406. [Errata, Clin Infect Dis 2005;41:1830, 2006;42:1219.] (Pubitemid 41581713)
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin- resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011;52(3):e18-e55.
7. Teflaro (ceftaroline fosamil): prescribing information. New York: Forest Laboratories, October 2012 (http://www.frx.com/pi/teflaro-pi.pdf).
8. Tygacil (tigecycline): prescribing information. New York: Pfizer, November 2012 (http://labeling.pfizer.com/showlabeling.aspx?id=491).
9. Vancomycin: prescribing information. New York: Pfizer, December 2010 (http://labeling.pfizer.com/ShowLabeling.aspx?id=661).
10. Vibativ (telavancin): prescribing information. San Francisco: Theravance, January 2012 (http://www.vibativ.com/docs/VIBATIV-PI-Final.pdf).
11. Zyvox (linezolid): prescribing information. New York: Pfizer, March 2012 (http://labeling.pfizer.com/showlabeling.aspx?id=649).
12. Cubicin (daptomycin): prescribing information. Lexington, MA: Cubist Pharmaceuticals, January 2013 (http://www.cubicin.com/pdf/ PrescribingInformation.pdf).
13. Active Bacterial Core Surveillance (ABCs) report: Emerging Infections Program Network - methicillin-resistant Staphylococcus aureus. Atlanta: Centers for Disease Control and Prevention, 2011 (http://www.cdc.gov/abcs/reports- findings/survreports/mrsa11.pdf).
14. Antimicrobial resistance surveillance in Europe 2011: annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net). Stockholm: European Centre for Disease Prevention and Control, 2012 (http://ecdc.europa.eu/en/publications/Publications/antimicrobial-resistance- surveillance-europe-2011.pdf).
15. Ball AT, Xu Y, Sanchez RJ, Shelbaya A, Deminski MC, Nau DP. Nonadherence to oral linezolid after hospitalization: a retrospective claims analysis of the incidence and consequence of claim reversals. Clin Ther 2010;32:2246-55.
16. Tice A. Oritavancin: a new opportunity for outpatient therapy of serious infections. Clin Infect Dis 2012;54:Suppl 3:S239-S243.
17. Belley A, McKay GA, Arhin FF, et al. Oritavancin disrupts membrane integrity of Staphylococcus aureus and vancomycin-resistant enterococci to effect rapid bacterial killing. Antimicrob Agents Chemother 2010;54:5369-71.
18. Belley A, Neesham-Grenon E, McKay G, et al. Oritavancin kills stationary-phase and biofilm Staphylococcus aureus cells in vitro. Antimicrob Agents Chemother 2009;53:918-25.
19. Zhanel GG, Schweizer F, Karlowsky JA. Oritavancin: mechanism of action. Clin Infect Dis 2012;54:Suppl 3:S214-S219.
20. McKay GA, Beaulieu S, Arhin FF, et al. Time-kill kinetics of oritavancin and comparator agents against Staphylococcus aureus, Enterococcus faecalis and Enterococcus faecium. J Antimicrob Chemother 2009;63:1191-9.
21. Arhin FF, Draghi DC, Pillar CM, Parr TR Jr, Moeck G, Sahm DF. Comparative in vitro activity profile of oritavancin against recent gram-positive clinical isolates. Antimicrob Agents Chemother 2009;53:4762-71.
22. Mendes RE, Farrell DJ, Sader HS, Jones RN. Oritavancin microbiologic features and activity results from the surveillance program in the United States. Clin Infect Dis 2012;54:Suppl 3:S203-S213.
23. Ambrose PG, Drusano GL, Craig WA. In vivo activity of oritavancin in animal infection models and rationale for a new dosing regimen in humans. Clin Infect Dis 2012;54:Suppl 3:S220-S228.
24. Rubino CM, Van Wart SA, Bhavnani SM, Ambrose PG, McCollam JS, Forrest A. Oritavancin population pharmacokinetics in healthy subjects and patients with complicated skin and skin structure infections or bacteremia. Antimicrob Agents Chemother 2009;53:4422-8.
25. Kumar A, Mann HJ, Keshtgarpour M, et al. In vitro characterization of oritavancin clearance from human blood by low-flux, high-flux, and continuous renal replacement therapy dialyzers. Int J Artif Organs 2011;34:1067-74.
26. Belley A, Arhin FF, Sarmiento I, Deng H, Rose W, Moeck G. Pharmacodynamics of a simulated single 1,200-milligram dose of oritavancin in an in vitro pharmacokinetic/pharmacodynamic model of methi-cillin- resistant Staphylococcus aureus infection. Antimicrob Agents Chemother 2013;57:205-11.
27. Dunbar LM, Milata J, McClure T, Wasilewski MM. Comparison of the efficacy and safety of oritavancin front-loaded dosing regimens to daily dosing: an analysis of the SIMPLIFI trial. Antimicrob Agents Chemother 2011;55:3476-84.
28. Guidance for Industry - acute bacterial skin and skin structure infections: developing drugs for treatment. Silver Spring, MD: Food and Drug Administration, 2010 (http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071185.pdf).
29. Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CHMP/EWP/558/95 REV 2) to address indication-specific clinical data (draft). London: European Medicines Agency Committee for Medicinal Products for Human Use, 2012 (http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/07/WC500129443. pdf).
30. Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H. Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis 2012;55:1114-21.
31. Snodgrass WR, Anderson T. Prontosil in erysipelas. BMJ 1937;2:101-4.
32. Idem. Sulfanilamide in the treatment of erysipelas. BMJ 1937;2:1167-59.
33. Spellberg B, Talbot GH, Boucher HW, et al. Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebo-controlled trials. Clin Infect Dis 2009;49:383-91.
34. Watkins PB, Desai M, Berkowitz SD, et al. Evaluation of drug-induced serious hepatotoxicity (eDISH): application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery. Drug Saf 2011;34:243-52.
35. Guidance for Industry - drug-induced liver injury: premarketing clinical evaluation. Silver Spring, MD: Food and Drug Administration, 2009 (http://www.fda.gov/downloads/Drugs/.../Guidances/UCM174090.pdf).
36. Rehm S, Campion M, Katz DE, Russo R, Boucher HW. Community-based outpatient parenteral antimicrobial therapy (CoPAT) for Staphylococcus aureus bacteraemia with or without infective endocarditis: analysis of the randomized trial comparing daptomycin with standard therapy. J Antimicrob Chemother 2009;63:1034-42.