Adults diagnosed with lower limbs erysipelas/ cellulitis MedDRA version: 20.0 Level: PT Classification code 10037632 Term: Pyoderma System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Amoxicillin 500 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Amoxicillin
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Assistance Publique - Hôpitaux de Paris (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients = 18 years • Affiliated to a social security scheme • Who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements • Clinical signs of lower limbs erysipelas = 5 days defined as: o Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS=8) • Shiver, feverish sensation or fever experienced by the patient = 5 days or fever measured by the physician = 38°C • Severity score = 3 scored on three criteria: edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe) • Absence of erysipelas = 12 mois • Absence of blisters • Absence of solid purpura (purple tablecloth not erasing at vitro-pressure) • Absence of cutaneous necrosis • Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria
Exclusion criteria: • Allergy to ß lactam, fructose intolerance • Weight 120 kg • Use of oral antibiotic within 5 days (excluding one or two antibiotic intake = 24 hours) • Dermohypodermitis requiring hospitalization • Erysipelas bilateral • Abscess • Lymphedema requiring permanent contention • Animal bite = 7 days • HIV positive • Patient with comorbidity: known active hepatitis, chronic kidney failure or hepatocellular insufficiency • Patient unable to temporarily stop a long-term treatment as antibiotics or corticosteroids, or NSAIDs • Patient under immunosuppressive or oncologic treatments = 6 months • Pregnant women or breastfeeding • Patient under guardianship or curatorship, legal protection or protection of justice • Participation in other biomedical drug research • Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that a short course (5 days) of amoxicillin 50 mg/kg is not inferior to the usual course (10 days) to achieve complete erysipelas remission at day 12+/-2 confirmed by a central independent committee blinded adjudicated from the intervention received, using photos and clinical datas. ;Secondary Objective: 1)To compare the rate of clinical remission 2)To compare the rate and number of patients without additional antibiotherapy for cellulitis 3)To compare the rate of recurrence at day 28 +/-2. 4)To compare the rate of adverse events for the two strategies. 5) To compare the rate of complete remission at day 7 +/-2 ;Primary end point(s): Taux de rémission complète à la fin du traitement oral (à J12+/-2). La résolution complète est définie par : 1/ la disparition des symptômes : fièvre (T°= 38°) ET douleur, chaleur, œdème et érythème au site de l’érysipèle avec score de sévérité inférieur ou égale à 1, 2/ absence d’une nouvelle ligne d’antibiothérapie pour dermohypodermite bactérienne ;Timepoint(s) of evaluation of this end point: 12 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Rate of clinical remission: the disappearance of fever (T°=38°) AND of pain, warmth tenderness erythema and edema at the site of erysipelas and for the cutaneous plaque a clinical severity score less than or equal to 1 at day 12 +/-2. 2) Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2. 3) Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between J12 and J28+/-2. 4) Rate of adverse event during the treatment and the follow up periods as reported by the patient. 5) Rate of clinical remission at day 7 +/- 2: the disappearance of fever (T°=38°) AND of pain, warmth tenderness erythema and edema at the site of erysipelas and for the cutaneous plaque a clinical severity score less than or equal to 1, without receiving additional antibiotherapy at day 7 +/- 2 ;Timepoint(s) of evaluation of this end point: 28 days after randomization | — |
Countries
France
Contacts
Public ContactDRCI - Hôpital Saint Louis
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed