Skip to main content
SpringerLink
Log in

Early Use of Ceftaroline Fosamil in the United States Veterans Health Care System

  • Original Research Article
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Background

Ceftaroline fosamil is US Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, but it is not known how ceftaroline is being used in real-world settings or how adverse effects (AEs) and mortality compare to clinical trials.

Objective

This study describes ceftaroline use, AEs, and mortality in US Veterans Health Administration (VHA) hospital patients.

Methods

This phase IV, population-based, epidemiologic study analyzed patients ≥18 years old who received one or more ceftaroline doses within 14 days of admission to 69 VHA hospitals in 41 US states/territories from 1 October 2010 to 30 September 2014. VHA repository data were linked using unique patient identifiers. Diagnoses and AEs were determined using ICD9-CM and CSS codes. Demographics, AEs within 30 days of therapy initiation, and all-cause in-hospital mortality were summarized using descriptive statistics.

Results

764 Patients met study criteria. Patients were 97% male and 56% White, with a median age of 61 years and a Charlson score of 6. Diagnoses included skin (40%), sepsis (30%), osteomyelitis (25%), diabetic foot (22%), pneumonia (16%), bacteremia (11%), endocarditis (6%), meningitis (2%), and device (2%) infections. Ceftaroline was used first-line (37%), second-line (56%), and third-line or greater (7%). Patients received ceftaroline a median of 3 days after hospital admission. All-cause in-hospital mortality rates were: overall (5%), skin (2%), sepsis (9%), osteomyelitis (3%), diabetic foot (1%), pneumonia (13%), bacteremia (6%), endocarditis (11%), meningitis (6%), and device (13%). Eosinophilia, leukopenia, leukocytosis, fibromyalgia, myalgia and myositis, and polymyalgia rates were <1% each.

Conclusions

Ceftaroline is used in VHA hospitals for various diagnoses. Mortality was low and comparable with rates from clinical trials. Additional studies comparing ceftaroline to other drugs used in similar situations are needed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Antibiotic resistance threats in the United States, 2013. Atlanta: United States Centers for Disease Control and Prevention (CDC); 2013. http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf. Last accessed 26 Sept 2016.

  2. Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010;51:641–50.

    Article  CAS  PubMed  Google Scholar 

  3. Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011;66(Suppl 3):iii53–9.

  4. Teflaro Package Insert, US Food and Drug Adminstration. 2016. http://www.allergan.com/assets/pdf/teflaro_pi. Last accessed 26 Sept 2016.

  5. Ho TT, Cadena J, Childs LM, Gonzalez-Velez M, Lewis JS 2nd. Methicillin-resistant Staphylococcus aureus bacteraemia and endocarditis treated with ceftaroline salvage therapy. J Antimicrob Chemother. 2012;67:1267–70.

    Article  CAS  PubMed  Google Scholar 

  6. Lin JC, Aung G, Thomas A, Jahng M, Johns S, Fierer J. The use of ceftaroline fosamil in methicillin-resistant Staphylococcus aureus endocarditis and deep-seated MRSA infections: a retrospective case series of 10 patients. J Infect Chemother. 2013;19:42–9.

    Article  PubMed  Google Scholar 

  7. Casapao AM, Davis SL, Barr VO, Klinker KP, Goff DA, Barber KE, Kaye KS, Mynatt RP, Molloy LM, Pogue JM, Rybak MJ. Large retrospective evaluation of the effectiveness and safety of ceftaroline fosamil therapy. Antimicrob Agents Chemother. 2014;58:2541–6.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Zasowski EJ, Trinh TD, Claeys KC, Casapao AM, Sabagha N, Lagnf AM, Klinker KP, Davis SL, Rybak MJ. Multicenter observational ftudy of ceftaroline fosamil for methicillin-resistant Staphylococcus aureus bloodstream infections. Antimicrob Agents Chemother. 2017;61:e02015–16. doi:10.1128/AAC.02015-16

  9. Evans JD, Udeani G, Cole P, Friedland HD. Ceftaroline fosamil for the treatment of acute bacterial skin and skin structure infections in obese patients. Postgrad Med. 2014;126:128–34.

    Article  PubMed  Google Scholar 

  10. Maggiore C, Pasquale T, Cole P, Friedland HD. Ceftaroline fosamil for treating skin and skin structure infections or community-acquired pneumonia in patients with renal insufficiency. Expert Rev Clin Pharmacol. 2015;8:141–53.

    Article  PubMed  Google Scholar 

  11. Udeani G, Evans J, Cole P, Friedland HD. Ceftaroline fosamil for the treatment of community-acquired bacterial pneumonia in elderly patients. Hosp Pract. 1995;2014(42):109–15.

    Google Scholar 

  12. Kaye KS, Udeani G, Cole P, Friedland HD. Ceftaroline fosamil for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia. Hosp Pract. 1995;2015(43):144–9.

    Google Scholar 

  13. Vazquez JA, Maggiore CR, Cole P, Smith A, Jandourek A, Friedland HD. Ceftaroline fosamil for the treatment of Staphylococcus aureus bacteremia secondary to acute bacterial skin and skin structure infections or community-acquired bacterial pneumonia. Infect Dis Clin Pract (Baltim Md). 2015;23:39–43.

    Article  Google Scholar 

  14. Furtek KJ, Kubiak DW, Barra M, Varughese CA, Ashbaugh CD, Koo S. High incidence of neutropenia in patients with prolonged ceftaroline exposure. J Antimicrob Chemother. 2016;71:2010–3.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. LaVie KW, Anderson SW, O’Neal HR Jr, Rice TW, Saavedra TC, O’Neal CS. Neutropenia associated with long-term ceftaroline use. Antimicrob Agents Chemother. 2015;60:264–9.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

The contents of this article do not necessarily represent the views of the US Department of Veterans Affairs or the US Government. Furthermore, Dr. Reveles is supported by the NIH/National Institute on Aging San Antonio Claude D. Pepper Older Americans Independence Center (1P30AG044271-01A1) Career Development (KL2) Program. Finally, Dr. Frei is supported by the National Center for Advancing Translational Sciences, NIH, through Grant UL1 TR001120. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Author information

Authors and Affiliations

  1. Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA

    Rachel S. Britt, Kirk E. Evoy, Grace C. Lee, Kelly R. Reveles, Kimberly M. Sorensen, Xavier Jones & Christopher R. Frei

  2. Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA

    Rachel S. Britt, Kirk E. Evoy, Grace C. Lee, Kelly R. Reveles, Kimberly M. Sorensen, Mary Bollinger & Christopher R. Frei

  3. University Health System, San Antonio, TX, USA

    Kirk E. Evoy & Christopher R. Frei

  4. South Texas Veterans Health Care System, San Antonio, TX, USA

    Xavier Jones, Mary Bollinger & Christopher R. Frei

Authors
  1. Rachel S. Britt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kirk E. Evoy
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Grace C. Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Kelly R. Reveles
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kimberly M. Sorensen
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Xavier Jones
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Mary Bollinger
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Christopher R. Frei
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Study concept and design: C.R.F., K.R.R., and G.C.L. Statistical analysis: C.R.F. Interpretation of data: All authors. Drafting of the manuscript: R.S.B., K.E.E., and C.R.F. Critical revision of the manuscript for important intellectual content: All authors. Study supervision: C.R.F.

Corresponding author

Correspondence to Christopher R. Frei.

Ethics declarations

Funding

This work was supported by Allergan Pharmaceuticals (formerly Forest Pharmaceuticals) [TEF-IT-41 to CRF’s institution].

Conflicts of Interest

CRF has received research grants, to his institution, for investigator-initiated cancer and infectious diseases research, from Allergan (formerly Forest), Bristol Myers Squibb, and Pharmacyclics in the past three years. RSB, KEE, GCL, KRR, KMS, XJ, and MB do not have any conflicts of interest to declare.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 30 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Britt, R.S., Evoy, K.E., Lee, G.C. et al. Early Use of Ceftaroline Fosamil in the United States Veterans Health Care System. Drugs 77, 1345–1351 (2017). https://doi.org/10.1007/s40265-017-0785-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-017-0785-2

Search

Navigation