Course of amoxicillin
DrugOral amoxicillin per os at 50 mg/kg/day
NCT Number: NCT07104552
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS≤8)
Exclusion criteria
Oral amoxicillin per os at 50 mg/kg/day
Time frame: At day 12 +/- 2
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 +/- 2
T<38°
Time frame: At day 12 +/- 2
the pain is measured from the numerical assessment (EN). The score is graded according to the following EN values:
Time frame: At day 12 +/- 2
It is graded according to the following values:
Time frame: At day 12 +/- 2
It is graded according to the following values:
Time frame: At day 12 +/- 2
absence of additional antibiotherapy for erysipelas/cellulitis
Time frame: At day 12 +/- 2
Time frame: at day 12+/- 2
Time frame: at day 12 and day 28+/- 2
Time frame: at day 12+/- 2
Time frame: at day 7 +/- 2
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Comparing Short to Standard Amoxicillin Course for Erysipelas: a Non-inferiority Randomized Controlled Trial
Acronym: SHAREII
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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