PHENOXYMETHYLPENICILLIN for Recurrent Erysipelas in lower limbs

Inclusion criteria

• {"criterion_text":"- Male or female\n- Able to participate and be followed up during the study period\n- ≥ 18 years of age\n- At least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization\n- The last recurrent erysipelas have to be diagnosed within the previous 3 months\n- BMI < 40 kg/m2 (no morbid obesity)\n- Able to apply the compression alone or with a helper (e.g., nurse, household member)\n- Affiliated with a social security regimen\n- Able to consent and written informed consent obtained from the participant\n- Able to understand the aims of the study and to comply with the requirements of the study"}

Exclusion criteria

• {"criterion_text":"- Any causes of immunosuppression: known HIV+ infection, organ transplantation, bone-marrow transplantation, immunosuppressive regimens for any disease, malignancy or lymphoproliferative disorder\n- Receiving antibiotic treatment for erysipelas\n- Received antibiotic prophylaxis for recurrent erysipelas in the year before randomization\n- Already wore effective compression therapy (worn at least 5 days a week) in the 3 months before randomization\n- Contraindication to compression therapy (ie arterial occlusive disease, heart failure)\n- History of known hypersensitivity to beta lactamines\n- Woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion in all women from 15 to 45 years old who have not had an ovariectomy.\n- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).\n- Participation in another interventional research with an investigational drug or medical device."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded.","definition_or_measurement_approach":"Proportion of patients experiencing at least one recurrence of erysipelas during the 1-year prophylaxis phase; assessment performed by an assessor who is blinded."}

Secondary endpoints

• {"endpoint_text":"- Time to the first confirmed recurrence of erysipelas.","definition_or_measurement_approach":"Time from randomization to first confirmed recurrence of erysipelas."}
• {"endpoint_text":"- Severity of recurrence: number of nights in hospital for cellulitis.","definition_or_measurement_approach":"Severity measured as number of nights hospitalized for cellulitis."}
• {"endpoint_text":"- Presence of skin necrosis or ulceration.","definition_or_measurement_approach":"Binary assessment of presence/absence of skin necrosis or ulceration."}
• {"endpoint_text":"- Assessment of adverse effects and serious adverse effects during the prophylaxis phase.","definition_or_measurement_approach":"Collection and assessment of adverse events and serious adverse events occurring during prophylaxis."}
• {"endpoint_text":"- Quality of life: Dermatology Life Quality Index and EQ-5D-5L","definition_or_measurement_approach":"Quality of life assessed using the Dermatology Life Quality Index (DLQI) and EQ-5D-5L questionnaires."}
• {"endpoint_text":"- Adherence: number of days per week that compression was worn (using a patient book).","definition_or_measurement_approach":"Adherence measured as number of days per week compression was worn, recorded in a patient book."}
• {"endpoint_text":"- Assessment of oedema by circumferential measurements and using the truncated cone formula.","definition_or_measurement_approach":"Oedema assessed via circumferential leg measurements and calculated volume using the truncated cone formula."}
• {"endpoint_text":"- Number of days per week that antibiotics is taken (using a patient book)","definition_or_measurement_approach":"Antibiotic intake adherence measured as number of days per week antibiotics taken, recorded in a patient book."}
• {"endpoint_text":"- Health-economic: Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (15%).","definition_or_measurement_approach":"Economic analysis estimating probability that experimental strategy is clinically and economically non-inferior to control for various economic non-inferiority margins, with a fixed clinical non-inferiority margin of 15%."}

France

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

07-07-2025

Processing Time Days

69

Number Of Sites

26

Number Of Participants

200

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France