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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 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 - BMC Infect. Dis. (2015)

Bottom Line: 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.This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes.

View Article: PubMed Central - PubMed

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

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).

No MeSH data available.


Related in: MedlinePlus

Proportion of patients achieving clinical success by day 2 and day 3: overall (a), by infection type (b), and by pathogen (c). Clinical success was defined as improvement or cure. a Odds ratio (OR) for vancomycin compared with daptomycin. b Clinical success rates by infection type, excluding the 4 daptomycin and 4 vancomycin patients with “other” infection types. c Clinical success rates by pathogen, includr known S. aureus infection for those patients with a culture. MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus. See Table 3 for sample sizes
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Fig2: Proportion of patients achieving clinical success by day 2 and day 3: overall (a), by infection type (b), and by pathogen (c). Clinical success was defined as improvement or cure. a Odds ratio (OR) for vancomycin compared with daptomycin. b Clinical success rates by infection type, excluding the 4 daptomycin and 4 vancomycin patients with “other” infection types. c Clinical success rates by pathogen, includr known S. aureus infection for those patients with a culture. MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus. See Table 3 for sample sizes

Mentions: Because all patients reached clinical success (i.e., improvement or cure) by the end of their inpatient stay, clinical success was defined for analysis purposes as success within 2 to 3 days of randomization. A greater proportion of daptomycin-treated than vancomycin-treated patients achieved clinical success by day 2 and day 3 (Fig. 2a). Although the unadjusted differences in clinical success were not significant, logistic regression analysis showed that vancomycin treatment, relative to daptomycin treatment, was associated with a decreased chance of achieving clinical success within 2 days (odds ratio [OR] = 0.498; 95 % confidence interval [CI], 0.249–0.997; P = 0.049). Significant variables in the 2-day response included count of SIRS (P = 0.041), Gram-negative infection (P = 0.006), and baseline vancomycin use (P = 0.031). Similarly, clinical success rates were not significantly different within 2 and 3 days of treatment when analyzed by infection type (Fig. 2b) or pathogen (Fig. 2c).Fig. 2


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 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 - BMC Infect. Dis. (2015)

Proportion of patients achieving clinical success by day 2 and day 3: overall (a), by infection type (b), and by pathogen (c). Clinical success was defined as improvement or cure. a Odds ratio (OR) for vancomycin compared with daptomycin. b Clinical success rates by infection type, excluding the 4 daptomycin and 4 vancomycin patients with “other” infection types. c Clinical success rates by pathogen, includr known S. aureus infection for those patients with a culture. MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus. See Table 3 for sample sizes
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4637139&req=5

Fig2: Proportion of patients achieving clinical success by day 2 and day 3: overall (a), by infection type (b), and by pathogen (c). Clinical success was defined as improvement or cure. a Odds ratio (OR) for vancomycin compared with daptomycin. b Clinical success rates by infection type, excluding the 4 daptomycin and 4 vancomycin patients with “other” infection types. c Clinical success rates by pathogen, includr known S. aureus infection for those patients with a culture. MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus. See Table 3 for sample sizes
Mentions: Because all patients reached clinical success (i.e., improvement or cure) by the end of their inpatient stay, clinical success was defined for analysis purposes as success within 2 to 3 days of randomization. A greater proportion of daptomycin-treated than vancomycin-treated patients achieved clinical success by day 2 and day 3 (Fig. 2a). Although the unadjusted differences in clinical success were not significant, logistic regression analysis showed that vancomycin treatment, relative to daptomycin treatment, was associated with a decreased chance of achieving clinical success within 2 days (odds ratio [OR] = 0.498; 95 % confidence interval [CI], 0.249–0.997; P = 0.049). Significant variables in the 2-day response included count of SIRS (P = 0.041), Gram-negative infection (P = 0.006), and baseline vancomycin use (P = 0.031). Similarly, clinical success rates were not significantly different within 2 and 3 days of treatment when analyzed by infection type (Fig. 2b) or pathogen (Fig. 2c).Fig. 2

Bottom Line: 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.This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes.

View Article: PubMed Central - PubMed

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

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).

No MeSH data available.


Related in: MedlinePlus