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Short Course of Amoxicillin for Erysipelas (SHARE)

Primary Purpose

Erysipelas

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Amoxicillin
Amoxicillin
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erysipelas focused on measuring Amoxicillin, Erysipelas, Short course

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Henri Mondor - Service de dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1:Short treatment

2:Usual treatment

Arm Description

amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.

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.

Outcomes

Primary Outcome Measures

Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)

Secondary Outcome Measures

Time to obtain disappearance of fever and local signs
Relapse rate
Recurrence rate
Frequency of adverse events

Full Information

First Posted
January 28, 2010
Last Updated
February 6, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France, Société de Dermatologie Française
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1. Study Identification

Unique Protocol Identification Number
NCT01059123
Brief Title
Short Course of Amoxicillin for Erysipelas
Acronym
SHARE
Official Title
Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient number of inclusion
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France, Société de Dermatologie Française

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erysipelas
Keywords
Amoxicillin, Erysipelas, Short course

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:Short treatment
Arm Type
Experimental
Arm Description
amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
Arm Title
2:Usual treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
50 mg/kg/24H ; Per Os ; 3 times/day 6 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
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 Measure Information:
Title
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
Time Frame
Day 30 ± 5
Secondary Outcome Measure Information:
Title
Time to obtain disappearance of fever and local signs
Time Frame
up to day 30 ± 5
Title
Relapse rate
Time Frame
end of treatment to day 30± 5
Title
Recurrence rate
Time Frame
day 30± 5 to day 95± 5
Title
Frequency of adverse events
Time Frame
30 days ± 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier CHOSIDOW, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor - Service de dermatologie
City
Créteil
State/Province
Ile de France
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

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Short Course of Amoxicillin for Erysipelas

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