Daptomycin versus Standard Therapy for Bacteremia and Endocarditis Caused by Staphylococcus aureus
Open accessAbstract
BACKGROUND: Alternative therapies for Staphylococcus aureus bacteremia and endocarditis are needed. METHODS: We randomly assigned 124 patients with S. aureus bacteremia with or without endocarditis to receive 6 mg of daptomycin intravenously per kilogram of body weight daily and 122 to receive initial low-dose gentamicin plus either an antistaphylococcal penicillin or vancomycin. The primary efficacy end point was treatment success 42 days after the end of therapy. RESULTS: Forty-two days after the end of therapy in the modified intention-to-treat analysis, a successful outcome was documented for 53 of 120 patients who received daptomycin as compared with 48 of 115 patients who received standard therapy (44.2 percent vs. 41.7 percent; absolute difference, 2.4 percent; 95 percent confidence interval, -10.2 to 15.1 percent). Our results met prespecified criteria for the noninferiority of daptomycin. The success rates were similar in subgroups of patients with complicated bacteremia, right-sided endocarditis, and methicillin-resistant S. aureus. Daptomycin therapy was associated with a higher rate of microbiologic failure than was standard therapy (19 vs. 11 patients, P=0.17). In 6 of the 19 patients with microbiologic failure in the daptomycin group, isolates with reduced susceptibility to daptomycin emerged; similarly, a reduced susceptibility to vancomycin was noted in isolates from patients treated with vancomycin. As compared with daptomycin therapy, standard therapy was associated with a nonsignificantly higher rate of adverse events that led to treatment failure due to the discontinuation of therapy (17 vs. 8, P=0.06). Clinically significant renal dysfunction occurred in 11.0 percent of patients who received daptomycin and in 26.3 percent of patients who received standard therapy (P=0.004). CONCLUSIONS: Daptomycin (6 mg per kilogram daily) is not inferior to standard therapy for S. aureus bacteremia and right-sided endocarditis. (ClinicalTrials.gov number, NCT00093067 [ClinicalTrials.gov].).
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In the registrational trial, daptomycin performed as well as vancomycin or beta-lactams in treating septic pulmonary emboli caused by S aureus.
“In the registrational trial, 13 however, this agent performed as well as vancomycin or β-lactams in treating septic pulmonary emboli caused by S aureus, reflecting the distinct pathogenesis of this syndrome as opposed to traditional pneumonia.”
From Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association (2015) · cites this paper as [13]
The Patients table reports septic pulmonary emboli at baseline in 10 daptomycin recipients and 13 standard-therapy recipients. The Outcome section finds daptomycin noninferior overall for S. aureus bacteremia and endocarditis, but does not report outcomes specifically for patients with septic pulmonary emboli. It therefore does not establish that the treatments performed equally well for that syndrome. (LLM, conf=0.85)
Experimental — accuracy not yet measuredDaptomycin has been evaluated in the treatment of Staphylococcus aureus bacteremia and infective endocarditis in a randomized controlled trial.
“daptomycin has been evaluated in the treatment of S aureus bacteremia and IE in a randomized, controlled trial.13”
In a registrational open-label multinational clinical trial comparing daptomycin monotherapy with therapy including low-dose gentamicin for the first four days, patients did equally well in either treatment arm.
“In a registrational open-label, multinational, clinical trial for the treatment of S aureus bacteremia or right-sided IE comparing the efficacy of daptomycin monotherapy with therapy that included low-dose (1 mg/kg IV every 8 hours or adjusted on the basis of renal function) gentamicin for the first 4 days, patients did equally well in either treatment arm.”
In the predefined subgroup with MRSA bacteremia, daptomycin demonstrated a 44.4% success rate compared with 31.8% for standard therapy; this difference was not statistically significant (absolute difference 12.6%, 95% CI -7.4 to 32.6; P=0.28).
“In the predefined subgroup of those with MRSA bacteremia, daptomycin demonstrated a 44.4% success rate compared with 31.8% for standard therapy; this difference was not statistically significant (absolute difference, 12.6%, 95% confidence interval, -7.4 to 32.6; P=0.28).”
The small number of patients with left-sided infective endocarditis enrolled in the trial prevented meaningful conclusions on the comparative efficacy of daptomycin in this infection.
“Importantly, the small number (n=18; 9 in each arm) of patients with left-sided IE enrolled in the trial prevented meaningful conclusions on the comparative efficacy of daptomycin in this infection.”
In the multinational trial of S aureus bacteremia and right-sided infective endocarditis, daptomycin at 6 mg/kg per day was noninferior to standard therapy with vancomycin or an antistaphylococcal penicillin plus low-dose short-course gentamicin.
“In the above-noted multinational trial 13 of S aureus bacteremia and right-sided IE, this agent (at 6 mg•kg -1 •d -1 ) was noninferior to standard therapy with vancomycin or an antistaphylococcal penicillin plus low-dose, short-course gentamicin.”
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- Authors
- Fowler, V. G., Boucher, H. W., Corey, G. R., Abrutyn, E., Karchmer, A. W., Rupp, M. E., Levine, D. P., Chambers, H. F., Tally, F. P., Vigliani, G. A., Cabell, C. H., Link, A. S., DeMeyer, I., Filler, S. G., Zervos, M., Cook, P., Parsonnet, J., Bernstein, J. M., Price, C. S., Forrest, G. N., Fätkenheuer, G., Gareca, M., Rehm, S. J., Brodt, H. R., Tice, A., & Cosgrove, S. E.
- Affiliations
- Duke Medical Center (US)
- Tufts Medical Center (US)
- Beth Israel Deaconess Medical Center (US)
- University of Nebraska Medical Center (US)
- Wayne State University (US)
- San Francisco General Hospital (US)
- Cubist Pharmaceuticals (United States) (US)
- Novant Health Forsyth Medical Center (US)
- Onze Lieve Vrouwziekenhuis Hospital (BE)
- Harbor–UCLA Medical Center (US)
- Corewell Health William Beaumont University Hospital (US)
- East Carolina University (US)
- Dartmouth–Hitchcock Medical Center (US)
- Dayton VA Medical Center (US)
- Denver Health Medical Center (US)
- University of Maryland, Baltimore (US)
- University of Cologne (DE)
- Lehigh Valley Hospital (US)
- Cleveland Clinic (US)
- Goethe University Frankfurt (DE)
- University of Hawaiʻi at Mānoa (US)
- Johns Hopkins University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-08-17
- Volume
- 355
- Issue
- 7
- Pages
- 653-665
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2002249283
- Semantic Scholar
- addb68898af31a21c382a93f6760f375b2257cee
- Cited by
- 1,459
- References
- 26
- Citations by year
- 2026: 24 · 2025: 36 · 2024: 40 · 2023: 56 · 2022: 49 · 2021: 47 · 2020: 56 · 2019: 61 · 2018: 53 · 2017: 50 · 2016: 65 · 2015: 89 · 2014: 76 · 2013: 104 · 2012: 95
- FWCI
- 86.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Pfizer
- GlaxoSmithKline
- Topics
- Health Sciences › Medicine › Epidemiology › Infective Endocarditis Diagnosis and Management
- Health Sciences › Medicine › Infectious Diseases › Antimicrobial Resistance in Staphylococcus
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Keywords
- daptomycin, Staphylococcus aureus bacteremia, infective endocarditis, right-sided endocarditis, methicillin-resistant Staphylococcus aureus, gentamicin, vancomycin, non-inferiority, vancomycin resistance, renal dysfunction
- MeSH terms
- Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Endocarditis, Bacterial, Female, Gentamicins, Humans, Male, Middle Aged, Penicillins, Staphylococcal Infections, Staphylococcus aureus, Vancomycin, Methicillin Resistance, Bacteremia, Treatment Outcome, Daptomycin
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