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Short Course of Amoxicillin for Erysipelas (SHARE)

This study is not yet open for participant recruitment.
Verified January 2010 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Ministry of Health, France
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01059123
First received: January 28, 2010
Last updated: September 9, 2011
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Erysipelas
 Drug: Amoxicillin
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 646
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 12 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059123

Contacts
Contact: Olivier CHOSIDOW, MD,PhD 33 (0) 1 49 81 25 01 olivier.chosidow@hmn.aphp.fr
Contact: Laurence LECLEACH, MD 33(1) 1 49 81 25 01 laurence.lecleach@free.fr

Locations
France
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     olivier.chosidow@hmn.aphp.fr    
Contact: Laurence LECLEACH, MD         laurence.lecleach@free.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Société de Dermatologie Française
Investigators
Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059123     History of Changes
Other Study ID Numbers: P071207, 2008-006794-32
Study First Received: January 28, 2010
Last Updated: September 9, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Amoxicillin
Erysipelas
Short course

Additional relevant MeSH terms:
Erysipelas
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
 Skin Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013