Clinical Trial: Short Course of Amoxicillin for Erysipelas

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas

Brief Summary: The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.

Detailed Summary: To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o) [ Time Frame: Day 30 ± 5 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to obtain disappearance of fever and local signs [ Time Frame: up to day 30 ± 5 ]
  • Relapse rate [ Time Frame: end of treatment to day 30± 5 ]
  • Recurrence rate [ Time Frame: day 30± 5 to day 95± 5 ]
  • Frequency of adverse events [ Time Frame: 30 days ± 5 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: January 28, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 6, 2014
Last Verified: February 2014