Comparing Short to Standard Amoxicillin Course for Erysipelas
ConditionErysipelas
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Erysipelas is an acute streptococcal skin infection, primarily affecting the lower limbs and easily diagnosed. In 2000, the French expert consensus conference validated oral amoxicillin at 3 to 4.5 gr per day for 10 to 20 days as a standard treatment, despite the lack of full market approval for erysipelas treatment. In practice, general practitioners (GPs) typically prescribe amoxicillin for around 10 days. In 2019, the Haute Autorité de Santé (HAS), one of the national French Health Authorities, recommended a 7-day antibiotic course for erysipelas, while no RCT was available. Reducing the length of antibiotic courses during acute infections is challenging but necessary to lower therapeutic costs, reduce the risk of bacterial resistance, and improve patient adherence to treatment.
This RCT aims to validate the use of a short course, specifically 5 days, of oral amoxicillin at 50 mg/kg to treat erysipelas, demonstrating its non-inferiority compared to the standard course. The primary objective is to show that a short course (5 days) of amoxicillin at 50 mg/kg is non-inferior to the usual course (10 days) in achieving complete erysipelas remission by day 12 ± 2. The primary end point will be confirmed by a central independent committee, blinded to the intervention received, using photos and clinical data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years
Affiliated to a social security scheme
Who have given written consent according to local regulatory requirements after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed,
Shiver, feverish sensation or fever experienced by the patient ≤ 5 days or fever measured by the physician ≥ 38°C
Disqualifiers
Allergy to ß lactam, fructose intolerance
Weight < 40 kg or > 105 kg
Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)
Erysipela/Cellulitis requiring hospitalization
Trial design
Design model
Parallel
Treatments tested in this trial
Course of amoxicillin
DrugOral amoxicillin per os at 50 mg/kg/day
Treatment groups
656 Participants
are divided into 2 treatment groupsGroup A: Amox5DaysExperimental treatment 1 intervention
Group B: Amox10DaysActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of complete remission. 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 the initial condition, i.e., erysipelas/cellulitis. The clinical severity score corresponds to the addition of the 3 score value of pain, warmth tenderness erythema and edema.
Time frame
At day 12 +/- 22
the disappearance of fever (T°≥ 38°)
T\<38°
Time frame
At day 12 +/- 23
the disappearance of pain
the pain is measured from the numerical assessment (EN). The score is graded according to the following EN values: * if EN = 0, this equates to score 0 (Absent) * If EN between 1 and 8, this corresponds to a score of 1 (Moderate) * IF IN \> 8, this corresponds to a score of 2 (Severe)
Time frame
At day 12 +/- 24
warmth tenderness erythema at the site of erysipela
It is graded according to the following values: * if absent, this equates to score 0 * If moderate, this corresponds to a score of 1 * if severe, this corresponds to a score of 2
Time frame
At day 12 +/- 2Secondary outcomes
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
Time frame
At day 12 +/- 22
Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2
Time frame
at day 12+/- 23
Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between day 12 and day 28+/- 2.
Time frame
at day 12 and day 28+/- 24
Rate of adverse event during the treatment and the follow up periods as reported by the patient
Time frame
at day 12+/- 2Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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