PMID- 21348765
OWN - NLM
STAT- MEDLINE
DCOM- 20110811
LR  - 20131121
IS  - 1557-8674 (Electronic)
IS  - 1096-2964 (Linking)
VI  - 12
IP  - 2
DP  - 2011 Apr
TI  - Prospective, non-comparative study of daptomycin for the treatment of superficial 
      and deep incisional surgical site infections.
PG  - 113-8
LID - 10.1089/sur.2008.106 [doi]
AB  - BACKGROUND: Skin infections, including surgical site infections (SSIs), usually 
      involve gram-positive pathogens and continue to be a leading cause of morbidity 
      and death among hospital patients. The increasing prevalence of 
      methicillin-resistant Staphylococcus aureus and other resistant strains 
      accentuates the need for effective and safe therapies for such infections. This 
      exploratory study evaluated the efficacy and safety of daptomycin in patients 
      with gram-positive SSI according to wound classification. METHODS: Eligible 
      patients had an SSI with onset < 30 days after surgery, positive gram stain or 
      culture at least three days before daptomycin therapy began, and three or more 
      clinical signs and symptoms of infection. The incisional SSI was classified as 
      superficial or deep according to the U.S. Centers for Disease Control and 
      Prevention criteria. Patients with organ-space infections were excluded, as were 
      those with major concomitant infections, foreign material in the incision that 
      could not be removed, previous systemic antimicrobial therapy, or creatinine 
      clearance < 30 mL/min. Daptomycin 4 mg/kg was administered intravenously once 
      daily for 7-14 days. The primary efficacy endpoint was clinical response at the 
      end of daptomycin therapy, and the safety assessment was based on adverse events 
      (AEs). RESULTS: Sixty-nine patients were enrolled, 60 of whom were evaluable for 
      efficacy. Extremity wounds predominated among superficial incisional SSIs (n = 
      30), whereas abdominal wounds predominated among deep SSIs (n = 30). Patients 
      with deep incisional SSI were more likely to be young, male, white, and febrile 
      and to weigh more than patients with superficial SSIs. The overall clinical 
      success rate was 92% (95% confidence interval [CI] 82-97%); the success rate was 
      100% in superficial incisional SSI and 83% in deep SSI (17% difference; 95% CI 
      0-33%). Staphylococcus aureus (28/36 methicillin-resistant) was the pathogen 
      isolated most frequently. In 10 patients who were febrile at baseline, the median 
      time to defervescence was five days, and the mean duration of treatment in the 
      series was 11.2 days. Daptomycin was well tolerated. In most patients, AEs were 
      mild or moderate in intensity; in two patients (one superficial, one deep), 
      daptomycin was discontinued because of AEs. CONCLUSIONS: The results of this 
      exploratory study of SSI are consistent with those of previous studies of 
      daptomycin in the treatment of diverse complicated skin and skin-structure 
      infections, and suggest that wound classification should be treated as an 
      important covariate in future studies of daptomycin and other antibiotics.
FAU - Knapp, Andrew G
AU  - Knapp AG
AD  - Cubist Pharmaceuticals Inc, Lexington, Massachusetts 02421, USA. 
      andy.knapp@cubist.com
FAU - Kamepalli, Ravi K
AU  - Kamepalli RK
FAU - Martone, William J
AU  - Martone WJ
FAU - Yankelev, Sara
AU  - Yankelev S
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110224
PL  - United States
TA  - Surg Infect (Larchmt)
JT  - Surgical infections
JID - 9815642
RN  - 0 (Anti-Bacterial Agents)
RN  - NWQ5N31VKK (Daptomycin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects
MH  - Daptomycin/*administration & dosage/adverse effects
MH  - Female
MH  - Gram-Positive Bacteria/isolation & purification
MH  - Gram-Positive Bacterial Infections/*drug therapy/microbiology/pathology
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Skin Diseases, Bacterial/*drug therapy/microbiology/pathology
MH  - Staphylococcus aureus
MH  - Surgical Wound Infection/*drug therapy/microbiology/pathology
MH  - Treatment Outcome
MH  - United States
EDAT- 2011/02/26 06:00
MHDA- 2011/08/13 06:00
CRDT- 2011/02/26 06:00
PHST- 2011/02/26 06:00 [entrez]
PHST- 2011/02/26 06:00 [pubmed]
PHST- 2011/08/13 06:00 [medline]
AID - 10.1089/sur.2008.106 [doi]
PST - ppublish
SO  - Surg Infect (Larchmt). 2011 Apr;12(2):113-8. doi: 10.1089/sur.2008.106. Epub 2011 
      Feb 24.