AMOXICILLIN SODIUM for Erysipelas (lower limb)

Inclusion criteria

• {"criterion_text":"-Patients ≥ 18 years"}
• {"criterion_text":"-Affiliated to a social security scheme"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Clinical signs of leg erysipelas ≤ 5 days defined by the association of : Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS≤8)"}
• {"criterion_text":"-Shiver, feverish sensation or fever experienced by the patient ≤ 5 days or fever measured by the physician ≥ 38°C"}
• {"criterion_text":"-Severity score ≥ 3 scored on three criteria : edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe)"}
• {"criterion_text":"-Absence of erysipelas ≤ 12 mois"}
• {"criterion_text":"-Absence of blisters"}
• {"criterion_text":"-Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)"}
• {"criterion_text":"-Absence of cutaneous necrosis"}
• {"criterion_text":"-Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema"}

Exclusion criteria

• {"criterion_text":"-Allergy to ß lactam, intolerance to fructose"}
• {"criterion_text":"-Weight < 40 kg or > 105 kg"}
• {"criterion_text":"-Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)"}
• {"criterion_text":"-Dermohypodermitis requiring hospitalization"}
• {"criterion_text":"-Erysipelas bilateral"}
• {"criterion_text":"-Abscess"}
• {"criterion_text":"-Lymphedema requiring permanent contention"}
• {"criterion_text":"-Animal bite ≤ 7 days"}
• {"criterion_text":"-HIV positive"}
• {"criterion_text":"-Patient with comorbidity: known active hepatitis, chronic kidney failure or hepatocellular insufficiency"}
• {"criterion_text":"-Patient unable to temporarily stop a long-term treatment as antibiotics or corticosteroids"}
• {"criterion_text":"-Anti-cancer, immunotherapy or immunosuppressive therapy ≤ 6 months"}
• {"criterion_text":"-Pregnant women or breastfeeding"}
• {"criterion_text":"-Patient under guardianship or curatorship, legal protection or protection of justice"}
• {"criterion_text":"-Participation in other Clinical Trial, interventional study, investigational study or performance study"}
• {"criterion_text":"-Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study"}

Primary endpoints

• {"endpoint_text":"-Rate of complete remission at day 12+/- 2. Complete remission is a composite outcome defined as 1) 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; and 2) the absence of additional antibiotherapy for cellulitis.","definition_or_measurement_approach":"Composite outcome as defined in the endpoint text; confirmation/adjudication performed by a central independent committee blinded to treatment allocation using photographs and clinical data."}

Secondary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Clinical remission assessed by disappearance of listed signs/symptoms at day 12±2."}
• {"endpoint_text":"-Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2","definition_or_measurement_approach":"Assessment of whether patients received additional antibiotic therapy by day 12±2 (binary count and rate)."}
• {"endpoint_text":"-Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between day 12 and day 28+/- 2.","definition_or_measurement_approach":"Recurrence measured as requirement for additional antibiotic therapy between day 12 and day 28±2."}
• {"endpoint_text":"-Rate of adverse event during the treatment and the follow up periods as reported by the patient.","definition_or_measurement_approach":"Adverse events captured and reported by the patient during treatment and follow-up periods; rates compared between arms."}
• {"endpoint_text":"-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, without receiving additional antibiotherapy at day 7 +/- 2","definition_or_measurement_approach":"Clinical remission assessed at day 7±2 with requirement of no additional antibiotic therapy."}

France

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

26-01-2026

Processing Time Days

476

Number Of Sites

35

Number Of Participants

656

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France