Novel developments in the treatment of acute bacterial skin and skin structure infections

Jaffa, Rupal K; Pillinger, Kelly E.; Roshdy, Danya; Isip, Jacqueline; Pasquale, Timothy R.

doi:10.1080/14656566.2019.1617851

Cited by 19 publications

(9 citation statements)

References 49 publications

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“…MRSA activity have been approved in the United States for treatment of acute bacterial skin and skin structure infections (ABSSSIs): ceftaroline fosamil, dalbavancin, delafloxacin, omadacycline, oritavancin, and tedizolid phosphate. Three of these agents (delafloxacin, omadacycline, and tedizolid phosphate) are available in both intravenous and oral forms (12)(13)(14)(15).…”

mentioning

confidence: 99%

Ceftobiprole Activity against Bacteria from Skin and Skin Structure Infections in the United States from 2016 through 2018

Flamm

Duncan

Hamed

et al. 2020

Antimicrob Agents Chemother

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Ceftobiprole medocaril is an advanced-generation cephalosporin prodrug that has qualified infectious disease product status granted by the US FDA and is currently being evaluated in phase 3 clinical trials in patients with acute bacterial skin and skin structure infections (ABSSSIs) and in patients with Staphylococcus aureus bacteremia. In this study, the activity of ceftobiprole and comparators was evaluated against more than 7,300 clinical isolates collected in the United States from 2016 through 2018 from patients with skin and skin structure infections. The major species/pathogen groups were S. aureus (53%), Enterobacterales (23%), Pseudomonas aeruginosa (7%), beta-hemolytic streptococci (6%), Enterococcus spp. (4%), and coagulase-negative staphylococci (2%). Ceftobiprole was highly active against S. aureus (MIC50/90, 0.5/1 mg/liter; 99.7% susceptible by EUCAST criteria; 42% methicillin-resistant S. aureus [MRSA]). Ceftobiprole also exhibited potent activity against other Gram-positive cocci. The overall susceptibility of Enterobacterales to ceftobiprole was 84.8% (>99.0% susceptible for isolate subsets that exhibited a non-extended-spectrum β-lactamase [ESBL] phenotype). A total of 74.4% of P. aeruginosa, 100% of beta-hemolytic streptococci and coagulase-negative staphylococci, and 99.6% of Enterococcus faecalis isolates were inhibited by ceftobiprole at ≤4 mg/liter. As expected, ceftobiprole was largely inactive against Enterobacterales that contained ESBL genes and Enterococcus faecium. Overall, ceftobiprole was highly active against most clinical isolates from the major Gram-positive and Gram-negative skin and skin structure pathogen groups collected at U.S. medical centers participating in the SENTRY Antimicrobial Surveillance Program during 2016 to 2018. The broad-spectrum activity of ceftobiprole, including potent activity against MRSA, supports its further evaluation for a potential ABSSSI indication.

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mentioning

confidence: 99%

Ceftobiprole Activity against Bacteria from Skin and Skin Structure Infections in the United States from 2016 through 2018

Flamm

Duncan

Hamed

et al. 2020

Antimicrob Agents Chemother

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“…drug–drug interactions, ability to transition from intravenous to oral therapy, efficacy and safety profile), patient characteristics (e.g. presence of comorbidities, age), causative pathogen(s) and local antimicrobial resistance patterns [ 48 – 50 ].…”

Section: Place Of Delafloxacin In the Management Of Absssismentioning

confidence: 99%

Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections

Scott

2020

Drugs

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The global spread of antibacterial-resistant strains, especially methicillin-resistant Staphylococcus aureus (MRSA) for acute bacterial skin and skin structure infections (ABSSSIs), has driven the need for novel antibacterials. Delafloxacin [Quofenix™ (EU); Baxdela ® (USA)], a new fluoroquinolone (FQ), has a unique chemical structure that enhances its antibacterial activity in acidic environments such as occurs in ABSSSIs (including S. aureus infections). Delafloxacin (intravenous and oral formulations) is approved in several countries for the treatment of adults with ABSSSIs (featured indication). In intent-to-treat analyses in pivotal phase 3 trials in adults with ABSSSIs, including those with comorbid disease, intravenous delafloxacin monotherapy (± oral switch after six doses) twice daily was noninferior to intravenous vancomycin + aztreonam for primary endpoints, as specified by the FDA (objective response rate at 48-78 h after initiation of therapy) and the EMA [investigator-assessed clinical cure rate at the follow-up visit at day 14 (± 1 day)]. Delafloxacin was generally well tolerated, with most treatment-related adverse events mild to moderate in severity and few patients discontinuing treatment because of these events. Relative to vancomycin + aztreonam (a non-FQ regimen), delafloxacin treatment was not associated with an increased risk of FQ-associated AEs of special interest. Given its unique chemical structure that confers novel properties relative to other FQ and its broad spectrum of activity against common clinically relevant Gram-positive pathogens, including against MRSA strains (± FQ-resistance mutations), and Gram-negative pathogens, intravenous delafloxacin (± oral switch) provides a novel emerging option for the treatment of adult patients with ABSSSIs.

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“…potential drug-drug interactions, efficacy and safety profiles, cost and ability for easy transition at discharge) and patient characteristics (e.g. presence of comorbidities) [1][2][3][4]. Vancomycin, linezolid, ceftaroline, daptomycin and clindamycin are among the recommended first-line parenteral antibacterial therapy in the 2014 Infectious Diseases Society of America practice guidelines for skin and soft tissue infections [4].…”

Section: What Is the Rationale For Developing A New Intravenous (Iv) ...mentioning

confidence: 99%

“…In an attempt to decrease healthcare costs and improve clinical outcomes, single-dose antibacterial treatments, such as oritavancin and dalbavancin, have been developed as an alternative to multi-dose and multi-day antibacterial treatment for ABSSSIs [3,9]. Oritavancin, a long-acting lipoglycopeptide, is the first single-dose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with ABSSSI caused by, or suspected to be caused by, susceptible gram-positive microorganisms [10,11].…”

Section: What Are the Antibacterial Effects Of Oritavancin?mentioning

confidence: 99%

Oritavancin (KIMYRSA™) in acute bacterial skin and skin structure infections: a profile of its use in the USA

Heo

2022

Drugs Ther Perspect

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Oritavancin, a long-acting lipoglycopeptide, is the first single-dose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated gram-positive microorganisms. With its well-established antibacterial activity, efficacy and safety profiles, a new IV formulation of oritavancin (KIMYRSA™) has been developed to offer a more convenient treatment option for patients with ABSSSIs. Relative to the originally approved IV formulation of oritavancin (ORBACTIV ® ), the new IV formulation has better diluent compatibility, simpler preparation steps, a shorter infusion time of 1 h in a lower infusion volume of 250 mL. Approval was based on results of a phase 1 study in which pharmacokinetic similarity between the two IV formulations of oritavancin was demonstrated in patients with ABSSSIs. The tolerability profile of the new IV formulation of oritavancin revealed no new safety signals. Plain Language SummaryAcute bacterial skin and skin structure infections (ABSSSIs) are heterogeneous bacterial infections that can pose a significant burden on healthcare systems. In an attempt to optimize patient outcomes and healthcare utilizations, single-dose regimens have been developed as an alternative to multi-dose and multi-day regimens for ABSSSIs. Oritavancin is the first singledose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with ABSSSIs. With its well-established efficacy and safety profiles, a new IV formulation of oritavancin (KIMYRSA™) has been developed, which has a shorter infusion time and a smaller infusion volume than the originally approved IV formulation (ORBACTIV ® ). The pharmacokinetic and safety profiles of oritavancin were similar between the two IV formulations. The new IV formulation of oritavancin is a convenient, effective treatment option for patients with ABSSSIs.

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Novel developments in the treatment of acute bacterial skin and skin structure infections

Cited by 19 publications

References 49 publications

Ceftobiprole Activity against Bacteria from Skin and Skin Structure Infections in the United States from 2016 through 2018

Ceftobiprole Activity against Bacteria from Skin and Skin Structure Infections in the United States from 2016 through 2018

Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections

Oritavancin (KIMYRSA™) in acute bacterial skin and skin structure infections: a profile of its use in the USA

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