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Comparing Short to Standard Amoxicillin Course for Erysipelas

Study acronym: SHAREII
StatusNot Yet Recruiting
PhasePhase 4
Started2026-01-01
View on ClinicalTrials.gov ↗

Amendment history

2025-08-07
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Study Identification, Study Status, Study Description, Outcome Measures v1
Primary endpoints6 entries, revised
absenceNumber of patients who did not receive any additional antibiotherapyantibiotics for erysipelas/cellulitis
Study title-47 characters
Comparing Short to Standard Amoxicillin Course for Erysipelas: a Non-inferiority Randomized Controlled Trial
2025-07-29
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Original filing
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 Details
NCT Number NCT07104552
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Erysipelas
Enrollment 656 participants
Start Date 2026-01-01
Primary Completion 2029-01-12 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-12