Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial
Matthew W McCarthy, Katelyn R Keyloun, Patrick Gillard, Justin J Choi, Nicholas Pickell, Ronald Copp, Thomas J Walsh, Matthew W McCarthy, Katelyn R Keyloun, Patrick Gillard, Justin J Choi, Nicholas Pickell, Ronald Copp, Thomas J Walsh
Abstract
Introduction: Admissions for acute bacterial skin and skin structure infections (ABSSSI) are often prolonged because of intravenous (IV) antibiotics. Use of a long-acting IV antibiotic may reduce length of stay (LOS) on a hospitalist service. The ENHANCE ABSSSI trial sought to determine the impact on LOS and work productivity in patients treated with a long-acting IV antibiotic, dalbavancin, vs. usual care at an urban tertiary-care center.
Methods: A single-center, pre- vs. post-period pragmatic trial at Weill-Cornell Medical Center assessed usual care for consecutively enrolled admitted ABSSSI patients during an observational period (pre-period). Identification and treatment of eligible admitted ABSSSI patients with dalbavancin were implemented in the post-period. Those with life-threatening infections, requiring multiple antibiotics/intensive care, or with unstable comorbidities were excluded. Outcomes were assessed over a 44-day follow-up period.
Results: Of 48 and 43 patients enrolled, respectively, in the pre- and post-periods, mean infection-related LOS was reduced in the post-period (3.2 days vs. 4.8 days; P = 0.003). Similar results were found in an adjusted LOS analysis. Work productivity and activity impairment outcomes significantly improved in the post-period (P ≤ 0.01). Complete response rates were similar: 50% (pre-period) and 57% (post-period). Among AEs identified, 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period. Few AEs were serious (n = 3; 7% post-period versus n = 1; 2% pre-period).
Conclusion: After implementing the ENHANCE ABSSSI pathway, LOS was significantly reduced by almost 2 days, with potential improvements in work productivity and ability to complete daily activities.
Trial registration: ClinicalTrials.gov identifier, NCT03233438.
Funding: Allergan plc.
Keywords: Acute bacterial skin and skin structure infection; Cost; Dalbavancin; Long-acting antibiotic.
Figures
References
- Centers for Medicare & Medicaid Services. CMS Quality Strategy. . Accessed 27 June 2019.
- Talan DA, Salhi BA, Moran GJ, et al. Factors associated with decision to hospitalize emergency department patients with skin and soft tissue infection. West J Emerg Med. 2015;16:89–97. doi: 10.5811/westjem.2014.11.24133.
- Gunderson CG, Cherry B, Fisher A. Mortality of hospitalized patients with cellulitis: a systematic review and meta-analysis. In: Presented at: Hospital Medicine, April 8–11, 2018; Orlando, FL.
- Pollack CV, Jr, Amin A, Ford WT, Jr, et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. J Emerg Med. 2015;48:508–519. doi: 10.1016/j.jemermed.2014.12.001.
- Keyloun KR, Weber DJ, Gardstein BM, et al. Economic burden of hospital admissions for patients with acute bacterial skin and skin structure infections in the United States. Hosp Pract. 1995;2018(46):278–286.
- Kaye KS, Patel DA, Stephens JM, et al. Rising United States hospital admissions for acute bacterial skin and skin structure infections: recent trends and economic impact. PLoS One. 2015;10:e0143276. doi: 10.1371/journal.pone.0143276.
- McDermott KW, Elixhauser A, Sun R. Trends in hospital inpatient stays in the United States, 2005-2014, Statistical brief #225. Healthcare Cost and Utilization Project (HCUP). Available at: . Accessed 27 June 2019.
- Almarzoky Abuhussain SS, Burak MA, Kohman KN, et al. Patient preferences for treatment of acute bacterial skin and skin structure infections in the emergency department. BMC Health Serv Res. 2018;18:932. doi: 10.1186/s12913-018-3751-0.
- Bosso JA, Casapao AM, Edwards J, et al. Clinical pathway for moderate to severe acute bacterial skin and skin structure infections from a US perspective: a roundtable discussion. Hosp Pract. 1995;2016(44):183–189.
- 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:e10–e52. doi: 10.1093/cid/ciu296.
- Tice AD, Rehm SJ, Dalovisio JR, et al. Practice guidelines for outpatient parenteral antimicrobial therapy. IDSA guidelines. Clin Infect Dis. 2004;38:1651–1672. doi: 10.1086/420939.
- Jensen IS, Lodise TP, Fan W, et al. Use of oritavancin in acute bacterial skin and skin structure infections patients receiving intravenous antibiotics: a US hospital budget impact analysis. Clin Drug Investig. 2016;36:157–168. doi: 10.1007/s40261-015-0365-8.
- Stenehjem E, Brown J, Goldwater S, Scoble P, Owens R, Jr. Factors driving emergency department revisits or hospitalization within 30 days post-discharge (DC) in patients with acute bacterial skin and skin structure infections (ABSSSI). In: Presented at: IDWeek October 7–11, 2015; San Diego, CA.
- Lane S, Johnston K, Sulham KA, et al. Identification of patient characteristics influencing setting of care decisions for patients with acute bacterial skin and skin structure infections: results of a discrete choice experiment. Clin Ther. 2016;38:531–544. doi: 10.1016/j.clinthera.2016.01.007.
- Dalvance® (dalbavancin) Full prescribing information. Parsippany: Durata Therapeutics US Ltd.; 2018.
- Garnock-Jones KP. Single-dose dalbavancin: a review in acute bacterial skin and skin structure infections. Drugs. 2017;77:75–83. doi: 10.1007/s40265-016-0666-0.
- Orbactiv® (oritavancin) Full prescribing information. Lincolnshire: Melinta Therapeutics, Inc; 2019.
- Centers for Medicare & Medicaid Services. HCAHPS: Patients’ Perspectives of Care Survey. Available at: . Accessed 27 June 2019.
- Marrie TJ, Lau CY, Wheeler SL, et al. A controlled trial of a critical pathway for treatment of community-acquired pneumonia Community-Acquired Pneumonia Intervention Trial Assessing Levofloxacin. CAPITAL Study Investigators. Community-Acquired Pneumonia Intervention Trial Assessing Levofloxacin. JAMA. 2000;283:749–755. doi: 10.1001/jama.283.6.749.
- Thiese MS. Observational and interventional study design types; an overview. Biochem Med (Zagreb) 2014;24:199–210. doi: 10.11613/BM.2014.022.
- Harris AD, McGregor JC, Perencevich EN, et al. The use and interpretation of quasi-experimental studies in medical informatics. J Am Med Inf Assoc. 2006;13:16–23. doi: 10.1197/jamia.M1749.
- Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454–463. doi: 10.1056/NEJMra1510059.
- Macpherson H. Pragmatic clinical trials. Complement Ther Med. 2004;12:136–140. doi: 10.1016/j.ctim.2004.07.043.
- US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment. . Accessed 15 May 2019.
- Ware J, Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–233. doi: 10.1097/00005650-199603000-00003.
- Reilly Associates. WPAI:SHP V2.0. . Accessed 21 Oct 2019
- Ektare V, Khachatryan A, Xue M, et al. Assessing the economic value of avoiding hospital admissions by shifting the management of gram + acute bacterial skin and skin-structure infections to an outpatient care setting. J Med Econ. 2015;18:1092–1101. doi: 10.3111/13696998.2015.1078339.
- LaPensee KT, Fan W. Economic burden of hospitalization with antibiotic treatment for bacteremia/sepsis in the US. In: Presented at: IDWeek Annual Meeting, October 17–21, 2012; San Diego, CA.
- Lodise TP, Fan W, Sulham KA. Economic impact of oritavancin for the treatment of acute bacterial skin and skin structure infections in the emergency department or observation setting: cost savings associated with avoidable hospitalizations. Clin Ther. 2016;38:136–148. doi: 10.1016/j.clinthera.2015.11.014.
- 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. doi: 10.1056/NEJMoa1310480.
- Ramdeen S, Boucher HW. Dalbavancin for the treatment of acute bacterial skin and skin structure infections. Expert Opin Pharmacother. 2015;16:2073–2081. doi: 10.1517/14656566.2015.1075508.
- Jauregui LE, Babazadeh S, Seltzer E, et al. Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections. Clin Infect Dis. 2005;41:1407–1415. doi: 10.1086/497271.
- Rappo U, Gonzalez PL, Puttagunta S, et al. Single-dose dalbavancin and patient satisfaction in an outpatient setting in the treatment of acute bacterial skin and skin structure infections. J Glob Antimicrob Resist. 2019;17:60–65. doi: 10.1016/j.jgar.2019.02.007.
- Kaiser Family Foundation. Hospital adjusted expenses per inpatient day by ownership. . Accessed 27 June 2019
Source: PubMed