An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.

November 23, 2015 at 3:59 pm

BMC Infect Dis. 2015 Nov 7;15:503.

Kauf TL1, McKinnon P2, Corey GR3, Bedolla J4, Riska PF5, Sims M6, Jauregui-Peredo L7, Friedman B8, Hoehns JD9, Mercier RC10, Garcia-Diaz J11, Brenneman SK12, Ng D13, Lodise T14.

Author information

1Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA. tkandrb@gmail.com

2Global Center for Scientific Affairs, Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA. peggy.mckinnon@merck.com

3Department of Medicine, Duke University Health System, Durham, NC, USA. g.corey@duke.edu

4University of Texas at Austin Dell Medical School, Austin, TX, USA. jbedolla@seton.org

5Albert Einstein College of Medicine Montefiore Medical Center, Bronx, NY, USA. priska@montefiore.org

6Infectious Diseases Research, William Beaumont Hospital, Royal Oak, MI, USA. matthew.sims@beaumont.edu

7Medical Research, Mercy Saint Vincent Medical Center, Toledo, OH, USA. luis_jauregui@mhsnr.org

8JM Still Burn Center at Doctors Hospital, Augusta, GA, USA. brucefriedman.md@gmail.com

9Northeast Iowa Medical Education Foundation, Waterloo, IA, USA. jhoehns@neimef.org

10Pharmacy and Medicine, University of New Mexico, Albuquerque, NM, USA. rmercier@salud.unm.edu

11Department of Infectious Diseases, Ochsner Clinic Foundation, New Orleans, LA, USA. jgarcia-diaz@ochsner.org

12Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA. susan.brenneman@optum.com

13Department of Emergency Medicine, Nassau University Medical Center, East Meadow, NY, USA. dng@numc.edu

14Albany College of Pharmacy and Health Sciences, Albany, NY, USA. thomas.lodise@acphs.edu

Abstract

BACKGROUND:

Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.

METHODS:

The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N=250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge.

RESULTS:

No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9 % to the total hospitalization cost, compared with 6.4 % for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR]=0.498, 95 % confidence interval [CI], 0.249-0.997; P<0.05).

CONCLUSION:

This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4637139/pdf/12879_2015_Article_1261.pdf

Entry filed under: Antimicrobianos, Bacterias, Bacteriemias, Infecciones en piel y tej blandos, Metodos diagnosticos, Resistencia bacteriana, Sepsis, Update. Tags: .

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