Short Course of Amoxicillin for Erysipelas (NCT01059123) | Clinical Trial Compass
TerminatedPhase 4
Short Course of Amoxicillin for Erysipelas
Stopped: Insufficient number of inclusion
France10 participantsStarted 2010-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treat…
What they're measuring
1
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)