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Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin.

ABSTRACT: The increase in hospitalization due to acute bacterial skin and skin structure infections (ABSSSI) caused by resistant pathogens supports the need for new treatment options. Antimicrobial options for ABSSSI that provide broad-spectrum coverage, including gram-negative pathogens and multidrug-resistant gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), are limited. Delafloxacin is a novel fluoroquinolone available as intravenous and oral formulations and is characterized by an increased efficacy in acidic environments and activity on bacterial biofilm. Delafloxacin displays enhanced in vitro activity against MRSA, and enterococci, while maintaining efficacy against gram-negative pathogens and anaerobes. Delafloxacin has been studied for the treatment of ABSSSI and respiratory infections. Phase III studies have demonstrated noninferiority of delafloxacin compared to vancomycin, linezolid, tigecycline, and the combination of vancomycin plus aztreonam in the treatment of ABSSSI. Due to its favorable pharmacokinetic characteristics, the wide spectrum of action, and the potential for sequential therapy, delafloxacin represents a promising option in the empirical and targeted treatment of ABSSSI, both in hospital- and in community-based care.

SUBMITTER: Righi E

PROVIDER: S-EPMC5894714 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin.

Righi Elda E Carnelutti Alessia A Vena Antonio A Bassetti Matteo M

Infection and drug resistance 20180404

The increase in hospitalization due to acute bacterial skin and skin structure infections (ABSSSI) caused by resistant pathogens supports the need for new treatment options. Antimicrobial options for ABSSSI that provide broad-spectrum coverage, including gram-negative pathogens and multidrug-resistant gram-positive bacteria, such as methicillin-resistant <i>Staphylococcus aureus</i> (MRSA), are limited. Delafloxacin is a novel fluoroquinolone available as intravenous and oral formulations and is ...[more]

PMID: 29670380

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Project description:Background and objectiveNearly 10% of all US hospital admissions are attributed to acute bacterial skin and skin structure infections (ABSSSIs). While most antibacterials used to treat these infections require multi-day and multi-dose regimens, a single-dose treatment is now available. The objective of this analysis is to estimate the annual budget impact of using single-dose oritavancin in patients with moderate to severe ABSSSIs receiving intravenous methicillin-resistant Staphylococcus aureus (MRSA)-active antibacterials from a US hospital perspective.MethodsA decision-analytic model based on current clinical practice was developed to estimate the economic impact of oritavancin. Utilization of antibacterials and rates of hospital admission were derived from the Premier Research Database. Demographic and clinical data were informed by the published literature and 2014 wholesale drug acquisition costs were used. Other costs were based on the published literature and Medicare National Limitation amounts. All costs were inflated to 2014 US dollars. Two base-case scenarios were considered: one for hospitals with ambulatory services and one for hospitals without ambulatory services.ResultsFor a US hospital with ambulatory services with 1000 ABSSSI patients receiving intravenous MRSA antibiotics annually, use of oritavancin in 26% of patients is estimated to reduce the total annual budget by 12.9% (US$1.23 million), or approximately US$1234.67 per patient. Total inpatient costs will be reduced by 22.3% (US$1.40 million) and outpatient costs will increase slightly by 1.7% (US$55,310). Pharmaceutical cost increases are offset by savings in the inpatient setting from fewer hospital admissions. Hospitals without ambulatory services are estimated to receive overall cost savings of 9.3% (US$0.63 million).ConclusionUse of single-dose oritavancin in select ABSSSI patients with suspected or confirmed MRSA involvement is estimated to save US hospitals approximately 9.3-12.9% per year by reducing hospital admissions and lowering drug administration burden.

Project description:BackgroundOmadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant Staphylococcus aureus. Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI.ObjectivesTo estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned.MethodsThe base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates.ResultsThe annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively.ConclusionThis hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.

Project description:IntroductionAcute bacterial skin and skin structure infections (ABSSSIs) are frequently treated in emergency departments (EDs) or observation units (OUs) initially with intravenous (IV) antibiotics before discharge on oral therapy. This study aims to describe ABSSSI patients discharged directly from EDs/OUs.MethodsThis is a retrospective cohort study of patients with ABSSSIs treated in EDs/OUs of the Detroit Medical Center from 2012 to 2014. Adults with less than 24 h of IV antibiotics without hospital admission were included. Demographics, clinical characteristics, and severity were compared between ED and OU patients. Resource utilization, including tissue and blood cultures, and use of radiographic analysis was also collected. The primary outcome was 96-h ED revisit/hospitalization.ResultsAnalysis included 308 patients; 219 ED and 89 OU. OU patients were significantly more likely to be obese, have COPD/asthma, be diagnosed with cellulitis, and meet at least one systemic inflammatory response syndrome (SIRS) criterion. Tissue cultures were obtained in 21.7% of abscesses in the ED; 67.9% were in uncomplicated abscesses. In the OU tissue cultures were obtained in 48.8% of abscesses and 37.5% were uncomplicated cases. Blood cultures were drawn in 18.3% of ED patients and 56.2% of OU patients, not significantly associated with the presence of SIRS criteria. Radiology was used in the diagnosis of ABSSSIs in 33.5% of ED versus 69.5% OU patients (p < 0.001), Plain film radiograph being the most common. Thirty patients revisited the ED or required hospitalization within 96 h, 23 from the ED (p = 0.479). Prior history of ABSSSI (adjusted odds ratio [aOR] = 2.382, 95% confidence interval [CI] 1.264-6.346) and location on torso/buttocks (aOR = 2.355, 95% CI 1.067-5.197) were independent predictors.ConclusionsThe low rate of ED revisit/hospitalization supports the use of OUs for low acuity ABSSSIs requiring initial IV therapy. Resource utilization within EDs/OUs for the management of ABSSSIs needs to be evaluated for unnecessary testing/procures.

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Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin.

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Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin.

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