Journal article
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
BMC infectious diseases, Vol.15(1), pp.503-503
11/07/2015
DOI: 10.1186/s12879-015-1261-9
PMCID: PMC4637139
PMID: 26547411
Abstract
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.
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.
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).
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.
ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).
Details
- Title: Subtitle
- 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
- Creators
- Teresa L Kauf - Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA. tkandrb@gmail.comPeggy McKinnon - Global Center for Scientific Affairs, Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA. peggy.mckinnon@merck.comG Ralph Corey - Department of Medicine, Duke University Health System, Durham, NC, USA. g.corey@duke.eduJohn Bedolla - University of Texas at Austin Dell Medical School, Austin, TX, USA. jbedolla@seton.orgPaul F Riska - Albert Einstein College of Medicine Montefiore Medical Center, Bronx, NY, USA. priska@montefiore.orgMatthew Sims - Infectious Diseases Research, William Beaumont Hospital, Royal Oak, MI, USA. matthew.sims@beaumont.eduLuis Jauregui-Peredo - Medical Research, Mercy Saint Vincent Medical Center, Toledo, OH, USA. luis_jauregui@mhsnr.orgBruce Friedman - JM Still Burn Center at Doctors Hospital, Augusta, GA, USA. brucefriedman.md@gmail.comJames D Hoehns - Northeast Iowa Medical Education Foundation, Waterloo, IA, USA. jhoehns@neimef.orgRenée-Claude Mercier - Pharmacy and Medicine, University of New Mexico, Albuquerque, NM, USA. rmercier@salud.unm.eduJulia Garcia-Diaz - Department of Infectious Diseases, Ochsner Clinic Foundation, New Orleans, LA, USA. jgarcia-diaz@ochsner.orgSusan K Brenneman - Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA. susan.brenneman@optum.comDavid Ng - Department of Emergency Medicine, Nassau University Medical Center, East Meadow, NY, USA. dng@numc.eduThomas Lodise - Albany College of Pharmacy and Health Sciences, Albany, NY, USA. thomas.lodise@acphs.edu
- Resource Type
- Journal article
- Publication Details
- BMC infectious diseases, Vol.15(1), pp.503-503
- DOI
- 10.1186/s12879-015-1261-9
- PMID
- 26547411
- PMCID
- PMC4637139
- NLM abbreviation
- BMC Infect Dis
- ISSN
- 1471-2334
- eISSN
- 1471-2334
- Publisher
- England
- Grant note
- UL1 TR001073 / NCATS NIH HHS
- Language
- English
- Date published
- 11/07/2015
- Academic Unit
- Pharmacy Practice and Science
- Record Identifier
- 9984065502002771
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