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

Teresa L. Kauf, Peggy McKinnon, G. Ralph Corey, John Bedolla, Paul F. Riska, Matthew Sims, Luis Jauregui-Peredo, Bruce Friedman, James D. Hoehns, Renée Claude Mercier, Julia Garcia-Diaz, Susan K. Brenneman, David Ng, Thomas Lodise

Research output: Contribution to journalArticle

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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 14days and 30days 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)

Original languageEnglish (US)
Article number503
JournalBMC Infectious Diseases
Volume15
Issue number1
DOIs
StatePublished - Nov 7 2015

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Daptomycin
Vancomycin
Randomized Controlled Trials
Skin
Infection
Drug Costs
Costs and Cost Analysis
Length of Stay
Therapeutics
Patient Acceptance of Health Care
Anti-Bacterial Agents
Patient Preference
Health Resources
Methicillin-Resistant Staphylococcus aureus
Health Personnel
Patient Selection
Inpatients
Decision Making
Patient Care
Hospitalization

Keywords

  • Antimicrobial
  • Complicated skin and skin structure infection
  • Daptomycin
  • Effectiveness
  • Pragmatic randomized clinical trial
  • Vancomycin

ASJC Scopus subject areas

  • Infectious Diseases

Cite this

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. / Kauf, Teresa L.; McKinnon, Peggy; Corey, G. Ralph; Bedolla, John; Riska, Paul F.; Sims, Matthew; Jauregui-Peredo, Luis; Friedman, Bruce; Hoehns, James D.; Mercier, Renée Claude; Garcia-Diaz, Julia; Brenneman, Susan K.; Ng, David; Lodise, Thomas.

In: BMC Infectious Diseases, Vol. 15, No. 1, 503, 07.11.2015.

Research output: Contribution to journalArticle

Kauf, TL, McKinnon, P, Corey, GR, Bedolla, J, Riska, PF, Sims, M, Jauregui-Peredo, L, Friedman, B, Hoehns, JD, Mercier, RC, Garcia-Diaz, J, Brenneman, SK, Ng, D & Lodise, T 2015, '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, no. 1, 503. https://doi.org/10.1186/s12879-015-1261-9
Kauf, Teresa L. ; McKinnon, Peggy ; Corey, G. Ralph ; Bedolla, John ; Riska, Paul F. ; Sims, Matthew ; Jauregui-Peredo, Luis ; Friedman, Bruce ; Hoehns, James D. ; Mercier, Renée Claude ; Garcia-Diaz, Julia ; Brenneman, Susan K. ; Ng, David ; Lodise, Thomas. / 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. In: BMC Infectious Diseases. 2015 ; Vol. 15, No. 1.
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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 14days and 30days 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)",
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AU - Bedolla, John

AU - Riska, Paul F.

AU - Sims, Matthew

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AU - Hoehns, James D.

AU - Mercier, Renée Claude

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