title: Comparing short to standard duration of antibiotic therapy for patients hospitalized with cellulitis (DANCE): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Recommended therapy duration for patients hospitalized with cellulitis is 10-14 days. Unnecessary use of antibiotics is one of the key factors driving resistance. Recent studies have shown that antibiotic therapy for cellulitis in outpatients can safely be shortened, despite residual inflammation. This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days.
  
  
  METHODS
  In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with cellulitis will be included. Cellulitis is defined as warmth, erythema, and induration of the skin and/or subcutaneous tissue, with or without pain (including erysipelas). All patients will initially be treated with intravenous flucloxacillin, and will be evaluated after 5-6 days. Those who have improved substantially (defined as being afebrile, and having a lower cellulitis severity score) will be randomized at day 6 between additional 6 days of oral flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of cellulitis on day 14 (disappearance of warmth and tenderness, improvement of erythema and edema), without the need of additional antibiotics for cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a cellulitis severity score until day 28, and VAS scores on pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total antibiotic use and health-care resource utilization up to day 90).
  
  
  CONCLUSIONS
  Inclusion is planned to start in Q2 2014.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360).
authors.affiliation: Center for Experimental and Molecular Medicine (CEMM), Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center, University of Amsterdam, Meibergdreef 9, room G2-130, 1105 AZ, Amsterdam, The Netherlands. d.r.cranendonk@amc.uva.nl.
authors.forename: Duncan R
authors.initials: DR
authors.lastname: Cranendonk
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: Jan M
authors.initials: JM
authors.lastname: Prins
authors.forename: W Joost
authors.initials: WJ
authors.lastname: Wiersinga
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002481:Cellulitis / Q000188:drug therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D006760:Hospitalization; D006801:Humans; D009426:Netherlands; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents