title: Clinical response at Day 3 of therapy and economic outcomes in hospitalized patients with acute bacterial skin and skin structure infection (ABSSSI).
abstract: OBJECTIVE
  The FDA recently issued guidance for the types of infections that should be included in trials to support an indication for antibacterial treatment. The latest FDA guidance recommends assessing response to drug therapy at 48 to 72 hours as the primary endpoint in clinical trials. This study evaluated clinical and economic outcomes among acute bacterial skin and skin structure infections (ABSSSI) patients hospitalized at a 3000-bed healthcare system in New Jersey.
  
  
  METHODS
  In this retrospective cohort analysis, adult ABSSSI patients hospitalized between July 2010 and December 2011 were stratified based on infection type: cellulitis/erysipelas and major cutaneous abscess, wound infection, and all ABSSSI. Initial antibiotic therapy was assessed by individual agent, regimen, and MRSA coverage. Day 3 response to initial antibiotic therapy was evaluated based on temperature and lesion cessation outcomes; clinical response rates were assessed by initial therapy and pathogen for each cohort. The impact of response on length of stay (LOS), cost of care, and antibiotic treatment duration were also evaluated.
  
  
  RESULTS
  Commonly used antibiotics included vancomycin, cefazolin, piperacillin-tazobactam, and ampicillin-sulbactam; over 40% of patients received empiric therapy with activity against MRSA. Clinical non-response to initial antimicrobial therapy at Day 3 was 39.9%, 30.3%, and 60.7%, for all ABSSSI, cellulitis/abscess, and wound infection patients, respectively. The cost of care among non-responders was over 1.5 times that of responders (p < 0.0001). Non-response to initial therapy was associated with a 3.7 day increase in duration of antibiotic treatment (p < 0.0001).
  
  
  CONCLUSIONS
  Results of this study demonstrate that a significant percentage of ABSSSI patients, particularly those with wound infection, were not achieving clinical response at Day 3 of therapy. Failure to respond to drug therapy is associated with substantial increases in LOS, antibiotic treatment duration, and cost of care.
  
  
  CONCLUSIONS
  This had the inherent limitations associated with a retrospective chart review; because data was initially collected for clinical rather than research purposes, certain information may have been absent, incomplete, or missed by data abstractors.
authors: Barnabas Health Care System, South Plainfield, NJ 07080, USA. samara@barnabashealth.org
authors: Shilpa
authors: S
authors: Amara
authors: Robert T
authors: RT
authors: Adamson
authors: Indu
authors: I
authors: Lew
authors: Xingyue
authors: X
authors: Huang
mesh_terms: D000368:Aged; D000667:Ampicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002437:Cefazolin / Q000627:therapeutic use; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010878:Piperacillin / Q000627:therapeutic use; D000077725:Piperacillin, Tazobactam Drug Combination; D012189:Retrospective Studies; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000382:microbiology; D013407:Sulbactam / Q000627:therapeutic use; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D000077725:Piperacillin, Tazobactam Drug Combination; C035444:sultamicillin; D014640:Vancomycin; D000667:Ampicillin; D010397:Penicillanic Acid; D002437:Cefazolin; D013407:Sulbactam; D010878:Piperacillin