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Comparing short to standard amoxicillin course for eRysipElas: a non-inferiority randomized controlled trial .SHARE II

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515306-61-00
Acronym
P150924
Enrollment
656
Registered
2024-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults diagnosed with lower limbs erysipelas

Brief summary

Rate of complete remission at day 12+/- 2. 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 cellulitis.

Detailed description

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., Rate and number of patients not receiving additional antibiotherapy 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., Rate of adverse event during the treatment and the follow up periods as reported by the patient., 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, without receiving additional antibiotherapy at day 7 +/- 2

Interventions

DRUGAMOXICILLIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of complete remission at day 12+/- 2. 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 cellulitis.

Secondary

MeasureTime frame
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., Rate and number of patients not receiving additional antibiotherapy 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., Rate of adverse event during the treatment and the follow up periods as reported by the patient., 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, without receiving additional antibiotherapy at day 7 +/- 2

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026