Short Course of Amoxicillin for Erysipelas
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erysipelas
Intervention: Amoxicillin (Drug); Amoxicillin (Drug)
Phase: Phase 4
Sponsored by: Assistance Publique - Hôpitaux de Paris
Official(s) and/or principal investigator(s):
Olivier CHOSIDOW, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - HÃ´pitaux de Paris
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
Official title: Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical cure rate defined as body temperature â‰¤ 37,5Â°and disappearance of the cutaneous plaque (score=o)
Time to obtain disappearance of fever and local signs
Frequency of adverse events
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Males and females â‰¥ 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
- TÂ°â‰¥ 38Â°5 at least once during the past 5 days or chills.
- Score â‰¥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
- 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
Locations and Contacts
HÃ´pital Henri Mondor - Service de dermatologie, CrÃ©teil, Ile de France 94000, France
Starting date: September 2010
Last updated: February 6, 2014