New drugs for methicillin-resistant Staphylococcus aureus skin and soft tissue infections.
Journal
Current opinion in infectious diseases
ISSN: 1473-6527
Titre abrégé: Curr Opin Infect Dis
Pays: United States
ID NLM: 8809878
Informations de publication
Date de publication:
01 04 2022
01 04 2022
Historique:
pubmed:
24
11
2021
medline:
7
5
2022
entrez:
23
11
2021
Statut:
ppublish
Résumé
Staphylococcus aureus is a pathogen incriminated in skin and soft tissue infections (SSTIs), with methicillin-resistant S. aureus (MRSA) becoming the predominant cause and representing a significant burden to the healthcare system. The last updated Infectious Diseases Society of America (IDSA) guidelines concerning MRSA infections and SSTIs management were published in 2011 and 2014, respectively. The UK updated guidelines for MRSA infection treatment were published in 2021. Older treatment options may be associated with toxicity and require frequent dosing. There is a paucity of recent reviews on the armamentarium of new agents for MRSA SSTIs treatment. Since 2005, several new antibiotics received a fast-track approval by the Food and Drug Administration (FDA) for SSTI treatment. These drugs include delafloxacin, omadacycline, tedizolid, ceftaroline, dalbavancin, oritavancin and telavancin. In this manuscript, we will review the data that led to these new drugs approval and discuss their advantages and disadvantages in MRSA SSTIs management. MRSA is a major cause of SSTIs. Several novel therapies covering MRSA were FDA-approved for SSTIs. However, the current IDSA guidelines for MRSA infection and SSTIs as well as the recently published UK guidelines on MRSA treatment only consider these drugs as alternative choices or do not mention them at all.
Identifiants
pubmed: 34812745
doi: 10.1097/QCO.0000000000000800
pii: 00001432-202204000-00008
doi:
Substances chimiques
Anti-Bacterial Agents
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
112-119Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Références
Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis 2014; 59:147–159.
King MD, Humphrey BJ, Wang YF, et al. Emergence of community-acquired methicillin-resistant Staphylococcus aureus USA 300 clone as the predominant cause of skin and soft-tissue infections. Ann Intern Med 2006; 144:309–317.
Moran GJ, Krishnadasan A, Gorwitz RJ, et al. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med 2006; 355:666–674.
Carleton HA, Diep BA, Charlebois ED, et al. Community-adapted methicillin-resistant Staphylococcus aureus (MRSA): population dynamics of an expanding community reservoir of MRSA. J Infect Dis 2004; 190:1730–1738.
Ray GT, Suaya JA, Baxter R. Incidence, microbiology, and patient characteristics of skin and soft-tissue infections in a U.S. population: a retrospective population-based study. BMC Infect Dis 2013; 13:252.
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; 308:50–59.
Edelsberg J, Taneja C, Zervos M, et al. Trends in US hospital admissions for skin and soft tissue infections. Emerg Infect Dis 2009; 15:1516–1518.
Klein EY, Mojica N, Jiang W, et al. Trends in methicillin-resistant Staphylococcus aureus hospitalizations in the United States, 2010-2014. Clin Infect Dis 2017; 65:1921–1923.
Lakhundi S, Zhang K. Methicillin-resistant Staphylococcus aureus: molecular characterization, evolution, and epidemiology. Clin Microbiol Rev 2018; 31:e00020–18.
Böncüoğlu E, Kiymet E, Çağlar İ, et al. Upward trend in the frequency of community-acquired methicillin-resistant Staphylococcus aureus as a cause of pediatric skin and soft tissue infections over five years: a cross-sectional study. Turk J Pediatr 2021; 63:200–205.
Planet PJ. Life after USA300: the rise and fall of a superbug. J Infect Dis 2017; 215: (Suppl 1): S71–S77.
Singhal H, Kaur K, Bailey AR. Skin and soft tissue infections: incision, drainage, and debridement: background, indications, contraindications. 2020 https://emedicine.medscape.com/article/1830144-overview . [Accessed 10 September 2021]
Tantranont N, Luque Y, Hsiao M, et al. Vancomycin-associated tubular casts and vancomycin nephrotoxicity. Kidney Int Rep 2021; 6:1912–1922.
Urakami T, Hamada Y, Oka Y, et al. Is trimethoprim/sulfamethoxazole-associated increase in serum creatinine a pseudo-elevation or true nephrotoxicity? J Infect Chemother 2021; 27:1193–1197.
Slimings C, Riley TV. Antibiotics and healthcare facility-associated Clostridioides difficile infection: systematic review and meta-analysis 2020 update. J Antimicrob Chemother 2021; 76:1676–1688.
Armstrong AW, Hekmatjah J, Kircik LH. Oral tetracyclines and acne: a systematic review for dermatologists. J Drugs Dermatol 2020; 19:s6–s13.
Moellering RC Jr. Current treatment options for community-acquired methicillin-resistant Staphylococcus aureus infection. Clin Infect Dis 2008; 46:1032–1037.
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:e18–e55.
Brown NM, Brown EM. Guideline Development Group. Treatment of methicillin-resistant Staphylococcus aureus (MRSA): updated guidelines from the UK. J Antimicrob Chemother 2021; 76:1377–1378.
208610s007,208611s006lbl.pdf [Internet]. [cited 22 August 2021]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf .
NUZYRA (omadacycline). 24.
sivextro_pi.pdf [Internet]. [cited 22 August 2021]. https://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf
O’Riordan W, McManus A, Teras J, et al. A comparison of the efficacy and safety of intravenous followed by oral delafloxacin with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections: a phase 3, multinational, double-blind, randomized study. Clin Infect Dis 2018; 67:657–666.
Pullman J, Gardovskis J, Farley B, et al. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother 2017; 72:3471–3480.
Tulkens PM, Van Bambeke F, Zinner SH. Profile of a novel anionic fluoroquinolone-delafloxacin. Clin Infect Dis Off Publ Infect Dis Soc Am 2019; 68: (Suppl 3): S213–S222.
Bassetti M, Hooper D, Tillotson G. Analysis of pooled Phase 3 safety data for delafloxacin in acute bacterial skin and skin structure infections. Clin Infect Dis 2019; 68: (Suppl 3): S233–S240.
Litwin JS, Benedict MS, Thorn MD, et al. A thorough QT study to evaluate the effects of therapeutic and supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother 2015; 59:3469–3473.
Hoover R, Hunt T, Benedict M, et al. Safety, tolerability, and pharmacokinetic properties of intravenous delafloxacin after single and multiple doses in healthy volunteers. Clin Ther 2016; 38:53–65.
Iregui A, Khan Z, Malik S, et al. Emergence of delafloxacin-resistant Staphylococcus aureus in Brooklyn, New York. Clin Infect Dis 2020; 70:1758–1760.
O’Riordan W, Green S, Overcash JS, et al. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections. N Engl J Med 2019; 380:528–538.
O’Riordan W, Cardenas C, Shin E, et al. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, noninferiority trial. Lancet Infect Dis 2019; 19:1080–1090.
Noel GJ, Draper MP, Hait H, et al. A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections. Antimicrob Agents Chemother 2012; 56:5650–5654.
Prokocimer P, De Anda C, Fang E, et al. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA 2013; 309:559–569.
Moran GJ, Fang E, Corey GR, et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, noninferiority trial. Lancet Infect Dis 2014; 14:696–705.
Feng J, Xiang F, Cheng J, et al. Comparative efficacy and safety of vancomycin, linezolid, tedizolid, and daptomycin in treating patients with suspected or proven complicated skin and soft tissue infections: an updated network meta-analysis. Infect Dis Ther 2021; 10:1531–1547.
Lan S-H, Lin W-T, Chang S-P, et al. Tedizolid versus linezolid for the treatment of acute bacterial skin and skin structure infection: a systematic review and meta-analysis. Antibiot Basel Switz 2019; 8:E137.
Lv X, Alder J, Li L, et al. Efficacy and safety of tedizolid phosphate versus linezolid in a randomized phase 3 trial in patients with acute bacterial skin and skin structure infection. Antimicrob Agents Chemother 2019; 63:e02252-18.
Righi E, Carnelutti A, Bassetti M. Current role of oxazolidinones and lipoglycopeptides in skin and soft tissue infections. Curr Opin Infect Dis 2019; 32:123–129.
Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med 2007; 357:380–390.
Frampton JE. Ceftaroline fosamil: a review of its use in the treatment of complicated skin and soft tissue infections and community-acquired pneumonia. Drugs 2013; 73:1067–1094.
Karlowsky JA, Hackel MA, Bouchillon SLK, et al. In vitro activity of ceftaroline against bacterial pathogens isolated from patients with skin and soft tissue and respiratory tract infections in the Middle East and Africa: AWARE global surveillance programme 2015-2018. J Glob Antimicrob Resist 2021; 24:249–256.
Corey GR, Wilcox MH, Talbot GH, et al. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65: (Suppl 4): iv41–iv51.
Wilcox MH, Corey GR, Talbot GH, et al. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65: (Suppl 4): iv53–iv65.
Santos PD, Davis A, Jandourek A, et al. Ceftaroline fosamil and treatment of acute bacterial skin and skin structure infections: CAPTURE study experience. J Chemother Florence Italy 2013; 25:341–346.
Teflaro-USPI-09_2019-2.pdf [Internet]. [cited 24 July 2021]. https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/Teflaro-USPI-09_2019-2.pdf
Deitchman A, de Jong D, Barbour A, Derendorf H. Ceftobiprole medocaril (BAL-5788) for the treatment of complicated skin infections. Expert Rev Anti Infect Ther 2016; 14:997–1006.
Noel GJ, Bush K, Bagchi P, et al. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis 2008; 46:647–655.
Overcash JS, Kim C, Keech R, et al. Ceftobiprole compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections: results of a phase 3, randomized, double-blind trial (TARGET). Clin Infect Dis 2020; 73:e1507–e1517.
Ceftobiprole FDA Approval Status [Internet]. Drugs.com. [cited 2 September 2021]. https://www.drugs.com/history/ceftobiprole.html
Estrada S, Lodise TP, Tillotson GS, Delaportas D. The Real-World Economic and Clinical Management of Adult Patients with Skin and Soft Tissue Infections (SSTIs) with Oritavancin: Data from Two Multicenter Observational Cohort Studies. Drugs - real world outcomes 2020; 7: (Suppl 1): 6–12.
022110s012lbl.pdf [Internet]. [cited 28 August 2021]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf
Stryjewski ME, Graham DR, Wilson SE, et al. Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis 2008; 46:1683–1693.
Chuan J, Zhang Y, He X, et al. Systematic review and meta-analysis of the efficacy and safety of telavancin for treatment of infectious disease: are we clearer? Front Pharmacol 2016; 7:330.
Dalvance_Final_PI_10_2018.pdf [Internet]. [cited 24 July 2021]. https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/Dalvance_Final_PI_10_2018.pdf
Boucher HW, Wilcox M, Talbot GH, et al. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med 2014; 370:2169–2179.
Monteagudo-Martínez N, Solís-García del Pozo J, Nava E, et al. Acute bacterial skin and skin-structure infections, efficacy of dalbavancin: a systematic review and meta-analysis. Expert Rev Anti Infect Ther 2020; 0:1–13.
orbactiv-prescribing-information.pdf [Internet]. [cited 24 July 2021]. http://www.orbactiv.com/pdfs/orbactiv-prescribing-information.pdf
Corey GR, Loutit J, Moeck G, et al. SOLO I and SOLO II investigators. Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies. Antimicrob Agents Chemother 2018; 62:e01919-17.
Huang DB, Hawser S, Gemmell CG, Sahm DF. In Vitro Activity of Iclaprim against Methicillin-Resistant Staphylococcus aureus Nonsusceptible to Daptomycin, Linezolid, or Vancomycin: A Pilot Study. Can J Infect Dis Med Microbiol 2017; 2017:3948626.
Noviello S, Magnet S, Hawser S, Huang DB. In vitro activity of Iclaprim against isolates in two phase 3 clinical trials (REVIVE-1 and -2) for acute bacterial skin and skin structure infections. Antimicrob Agents Chemother 2019; 63:e02239–e2318.
Schneider P, Hawser S, Islam K. Iclaprim, a novel diaminopyrimidine with potent activity on trimethoprim sensitive and resistant bacteria. Bioorg Med Chem Lett 2003; 13:4217–4221.
Holland TL, O’Riordan W, McManus A, et al. A phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous Iclaprim versus vancomycin for treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens (REVIVE-2 Study). Antimicrob Agents Chemother 2018; 62:e02580-17.
Huang DB, O’Riordan W, Overcash JS, et al. A phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous Iclaprim Vs vancomycin for the treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens: REVIVE-1. Clin Infect Dis 2018; 66:1222–1229.
FDA Issues Complete Response Letter for Iclaprim [Internet]. Contagion Live. [cited 22 August 2021]. https://www.contagionlive.com/view/fda-issues-complete-response-letter-for-iclaprim
Bassetti M, Castaldo N, Carnelutti A, et al. Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy. Core Evid 2019; 14:31–40.
Dunne MW, Puttagunta S, Giordano P, et al. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis 2016; 62:545–551.
Leuthner KD, Buechler KA, Kogan D, et al. Clinical efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Ther Clin Risk Manag 2016; 12:931–940.
Ong V, Flanagan S, Fang E, et al. Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Drug Metab Dispos Biol Fate Chem 2014; 42:1275–1284.