Authorised Therapeutic use (Phase IV) Adults diagnosed with lower limbs erysipelas

SHort course of Amoxicilline for eRysipElas II

EU CTIS ID: 2024-515306-61-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients ≥ 18 years
  • Absence of cutaneous necrosis
  • Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema
  • 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 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)

You likely can't join if

  • Allergy to ß lactam, intolerance to fructose
  • 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
  • Anti-cancer, immunotherapy or immunosuppressive therapy ≤ 6 months
  • Pregnant women or breastfeeding
  • Patient under guardianship or curatorship, legal protection or protection of justice
See the full eligibility criteria
Who can join
  • Patients ≥ 18 years
  • Absence of cutaneous necrosis
  • Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema
  • 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 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)
  • 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)
What rules you out
  • Allergy to ß lactam, intolerance to fructose
  • 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
  • Anti-cancer, immunotherapy or immunosuppressive therapy ≤ 6 months
  • Pregnant women or breastfeeding
  • Patient under guardianship or curatorship, legal protection or protection of justice
  • Participation in other Clinical Trial, interventional study, investigational study or performance study
  • Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study
  • Weight < 40 kg or > 105 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.