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Short Course of Amoxicillin for Erysipelas (SHARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059123
Recruitment Status : Terminated (Insufficient number of inclusion)
First Posted : January 29, 2010
Last Update Posted : February 7, 2014
Ministry of Health, France
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Erysipelas Drug: Amoxicillin Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1:Short treatment
amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
Drug: Amoxicillin
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.
Drug: Amoxicillin
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.

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

Secondary Outcome Measures :
  1. Time to obtain disappearance of fever and local signs [ Time Frame: up to day 30 ± 5 ]
  2. Relapse rate [ Time Frame: end of treatment to day 30± 5 ]
  3. Recurrence rate [ Time Frame: day 30± 5 to day 95± 5 ]
  4. Frequency of adverse events [ Time Frame: 30 days ± 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • First episode of erysipelas of a lower leg defined as

    • acute well delineate inflammation than had lasted less than 5 days
    • T°≥ 38°5 at least once during the past 5 days or chills.
    • Score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe
  • Written informed consent provided by the patient
  • available health insurance
  • accept conditions of the trial

Exclusion Criteria:

  • Erysipelas for more than 5 days
  • Score < 3
  • Septic shock
  • Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
  • Past history of erysipelas of the same lower leg
  • Erysipelas not on the lower leg
  • Bilateral erysipelas
  • Bite occuring during the preceding 7 days.
  • Diabetic foot
  • patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours)
  • History of any hypersensitivity or allergic reaction to beta-lactam drugs
  • Known renal or Hepatic failure
  • Known HIV infection
  • Female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control
  • Impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs.
  • Severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment.
  • Denied to sign written informed consent
  • Unable or unwilling to adhere to the study-specified procedures and restrictions
  • Evolutive cancer under treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059123

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Hôpital Henri Mondor - Service de dermatologie
Créteil, Ile de France, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Société de Dermatologie Française
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Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01059123    
Other Study ID Numbers: P071207
2008-006794-32 ( EudraCT Number )
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Short course
Additional relevant MeSH terms:
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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents