Clinical Trial: Duration of ANtibiotic Therapy for CEllulitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Duration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized With Cellulitis

Brief Summary: Cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.

Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome:

  • Part 1/2: Resolution... [ Time Frame: day 14 ]
    Resolution of cellulitis at day 14, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema
  • Part 2/2: ...without relapse [ Time Frame: day 28 ]
    No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence at day 90 [ Time Frame: 90 days ]
    Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis
  • Objective speed of recovery [ Time Frame: Up to 90 days ]
    Improvement in cellulitis severity score (a 7 item scoring system, each with a score between 0-3; items are erythema, warmth, tenderness, edema, ulceration, drainage and fluctuance). Determined at day 1, day 2-3, day 5-6, day 14, and day 28
  • Health related Quality of Life [ Time Frame: Up to 90 days ]
    Using questionnaires Dutch SF-36 and EQ-5D at day 1, day 28, and day 90
  • Health care resource utilisation [ Time Frame: Up to 90 days ]
    Determined by total antibiotic use and effect on direct and indirect health-care associated costs, using modified versions of iMTA's Productivity Cost Questionnaire (iPCQ) and Medical Consumption Questionnaire (iMCQ). Measured at day 5-6, day 28 and day 90.
  • Subjective speed of recovery [ Time Frame: Up to 90 days ]
    Visual Analog Scales (0-10) on pain and on swelling. Determined at day 1, day 2-3, day 5-6, day 14, day 28, and day 90
  • Additional antibiotic usage [ Time Frame: Up to 90 days ]
    Total usage of additional antibiotics for cellulitis between the end of treatment and day 90.
  • Time to relapse [ Time Frame: Up to 90 days ]
    Time between end of treatment and the need for additional antibiotics for cellulitis


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: January 8, 2014
Date Started: August 2014
Date Completion: March 2018
Last Updated: January 23, 2017
Last Verified: January 2017