Short Course of Amoxicillin for Erysipelas

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France; Société de Dermatologie Française
• Treatments: Amoxicillin

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