Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01059123
Recruitment Status : Terminated (Insufficient number of inclusion)
First Posted : January 29, 2010
Last Update Posted : February 7, 2014
Sponsor:
Collaborators:
Ministry of Health, France
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE January 28, 2010
First Posted Date  ICMJE January 29, 2010
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Course of Amoxicillin for Erysipelas
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erysipelas
Intervention  ICMJE
  • Drug: Amoxicillin
    50 mg/kg/24H ; Per Os ; 3 times/day 6 days
  • 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.
Study Arms  ICMJE
  • Experimental: 1:Short treatment
    amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
    Intervention: Drug: Amoxicillin
  • 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.
    Intervention: Drug: Amoxicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)
646
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059123
Other Study ID Numbers  ICMJE P071207
2008-006794-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Ministry of Health, France
  • Société de Dermatologie Française
Investigators  ICMJE
Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP