Short Course of Amoxicillin for Erysipelas (SHARE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas|
- Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o) [ Time Frame: Day 30 ± 5 ] [ Designated as safety issue: No ]
- Time to obtain disappearance of fever and local signs [ Time Frame: up to day 30 ± 5 ] [ Designated as safety issue: No ]
- Relapse rate [ Time Frame: end of treatment to day 30± 5 ] [ Designated as safety issue: No ]
- Recurrence rate [ Time Frame: day 30± 5 to day 95± 5 ] [ Designated as safety issue: No ]
- Frequency of adverse events [ Time Frame: 30 days ± 5 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 1:Short treatment
amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
50 mg/kg/24H ; Per Os ; 3 times/day 6 days
Active Comparator: 2:Usual treatment
amoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14.
50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14.
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.
|Contact: Olivier CHOSIDOW, MD,PhD||33 (0) 1 49 81 25 email@example.com|
|Contact: Laurence LECLEACH, MD||33(1) 1 49 81 25 firstname.lastname@example.org|
|Hôpital Henri Mondor - Service de dermatologie||Not yet recruiting|
|Créteil, Ile de France, France, 94000|
|Contact: Olivier CHOSIDOW, MD,PhD +33 (0) 1 49 81 25 01 email@example.com|
|Contact: Laurence LECLEACH, MD firstname.lastname@example.org|
|Principal Investigator:||Olivier CHOSIDOW, MD,PhD||Assistance Publique - Hôpitaux de Paris|