ErysipelasPhase 4SHAREIINCT07104552
Comparing Short to Standard Amoxicillin Course for Erysipelas
A Phase 4 study testing Course of amoxicillin in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erysipelas
- What is being tested?
- Course of amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- Clinical signs of lower limbs erysipelas ≤ 5 days defined as:
- o 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
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- Severity score ≥ 3 scored on three criteria: edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe)
- Absence of erysipela ≤ 12 months
- Absence of blisters
- Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)
- Absence of cutaneous necrosis
- Absence of crepitation (crepitation = perception identical to that of cutaneous emphysema
Who cannot join
- 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
- Bilateral erysipela
- Abscess
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- Lymphedema requiring permanent contention
- Animal bite ≤ 7 days
- HIV positive
- 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, or NSAIDs
- Patient under immunosuppressive or oncologic treatments ≤ 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Olivier Chosidow, PhD contact
About this study
Official title: Comparing Short to Standard Amoxicillin Course for Erysipelas: a Non-inferiority Randomized Controlled 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.
- Conditions
- Erysipelas
- Being tested
- Course of amoxicillin
- Keywords
- dermatology, Erysipela, amoxixillin, general practitioner
- Medical subject headings
- Erysipelas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Course of amoxicillinDrug
Oral amoxicillin per os at 50 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Amox5Days | Experimental | Amoxicillin 50 mg/kg for five days Receives: Drug: Course of amoxicillin |
| Amox10Days | Active comparator | Amoxicillin 50 mg/kg for ten days Receives: Drug: Course of amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete remission. Complete remission is a composite outcome defined as
- 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
- 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.
Measured: At day 12 +/- 2
the disappearance of fever (T°≥ 38°)
T<38°
Measured: At day 12 +/- 2
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)
Measured: At day 12 +/- 2
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
Measured: At day 12 +/- 2
edema 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
Measured: At day 12 +/- 2
Number of patients who did not receive any additional antibiotics for erysipelas/cellulitis
absence of additional antibiotherapy for erysipelas/cellulitis
Measured: At day 12 +/- 2
Secondary outcomes (5)
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
Measured: At day 12 +/- 2
Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2
Measured: at day 12+/- 2
Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between day 12 and day 28+/- 2.
Measured: at day 12 and day 28+/- 2
Rate of adverse event during the treatment and the follow up periods as reported by the patient
Measured: at day 12+/- 2
Rate of clinical remission: disappearance of fever (≥38) AND 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, without receiving additional antibiotherapy
Measured: at day 7 +/- 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion12 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErysipelasStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- France Guyot, Study chair, Assistance Publique Hôpitaux de Paris - DRCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104552
- Sponsor's protocol ID
- P150924
- Other IDs
- 2024-515306-61-00
- Acronym
- SHAREII
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Short to Standard Amoxicillin Course for Erysipelas: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07104552
- Acronym / sponsor ID
- SHAREII / P150924
- Conditions
- Erysipelas
- Keywords
- dermatology, Erysipela, amoxixillin, general practitioner
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 12 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amox5Days | Experimental | Drug: Course of amoxicillinAmoxicillin 50 mg/kg for five days |
| Amox10Days | Active comparator | Drug: Course of amoxicillinAmoxicillin 50 mg/kg for ten days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
- Clinical signs of lower limbs erysipelas ≤ 5 days defined as:
- o Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS≤8)
Key exclusion criteria (15 listed)
- 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
- Bilateral erysipela
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Course of amoxicillinOral amoxicillin per os at 50 mg/kg/day | Drug | Amox10Days, Amox5Days |
Primary outcome
Rate of complete remission. Complete remission is a composite outcome defined as
Time frame: At day 12 +/- 2
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.
the disappearance of fever (T°≥ 38°)
Time frame: At day 12 +/- 2
T<38°
the disappearance of pain
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: * 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)
warmth tenderness erythema at the site of erysipela
Time frame: At day 12 +/- 2
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
edema at the site of erysipela
Time frame: At day 12 +/- 2
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
Number of patients who did not receive any additional antibiotics for erysipelas/cellulitis
Time frame: At day 12 +/- 2
absence of additional antibiotherapy for erysipelas/cellulitis
5 secondary outcomes
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 +/- 2
Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2
Time frame: at day 12+/- 2
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+/- 2
Rate of adverse event during the treatment and the follow up periods as reported by the patient
Time frame: at day 12+/- 2
Rate of clinical remission: disappearance of fever (≥38) AND 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, without receiving additional antibiotherapy
Time frame: at day 7 +/- 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Related trials for Erysipelas
Not yet recruitingPhase 4
Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy.
Recurrent Erysipelas
Recruiting
Hospital at Home for Elderly Acute Ill Patients
Cystitis, Erysipelas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier Chosidow, PhD contact
France Guyot study chair
Assistance Publique Hôpitaux de Paris - DRCI
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Course of amoxicillin in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tu-Anh Duong, PhD (+ 33 1 49 09 44 29, tu-anh.duong@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete remission. Complete remission is a composite outcome defined as (time frame: At day 12 +/- 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.