Short Course of Amoxicillin for Erysipelas (SHARE)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 4

Conditions

Erysipelas

Treatments

Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT01059123

2008-006794-32 (EudraCT Number)

P071207

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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