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Compression vs Antibiotics Non-Inferiority Phase 4 Erysipelas Trial

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Summary

The NIH ClinicalTrials.gov registry records a Phase 4 randomized controlled trial comparing compression therapy alone versus compression therapy plus oral penicillin for prophylaxis of recurrent erysipelas, a streptococcal infection affecting the lower limbs. The trial, registered as NCT07549594, enrolls patients who have experienced at least 2 episodes of erysipelas in the same limb within 1 year, a condition with 10-30% recurrence rates extending to 50% in some populations. Researchers and clinicians may use this registry record to identify ongoing trials and monitor progression toward published outcomes in the peer-reviewed literature.

“Each episode of erysipelas may worsen preexisting lymphedema and evolve to life-threatening necrotizing soft-tissue infection.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registry record adds a Phase 4 clinical trial to the public research database. The trial tests whether supervised compression therapy alone is non-inferior to supervised compression therapy combined with oral phenoxymethylpenicillin in preventing recurrence of erysipelas in patients with recurrent episodes in the same lower limb.

Affected parties, including clinical investigators, infectious disease researchers, and dermatology specialists, may use this registry entry to identify ongoing non-inferiority research and track future publications of comparative efficacy outcomes. The trial's findings may inform future prophylaxis guidelines if compression monotherapy is found non-inferior to the combination approach.

Archived snapshot

Apr 25, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy.

Phase 4 NCT07549594 Kind: PHASE4 Apr 24, 2026

Abstract

Erysipelas (superficial cellulitis) is a frequent streptococcal bacterial infection. Each episode of erysipelas may worsen preexisting lymphedema and evolve to life-threatening necrotizing soft-tissue infection. Moreover, each attack of cellulitis may worsen lymphatic damage and therefore favour additional attacks. Recurrence is frequent: 10-30% of cases and even up to 50%. In this context, at least 2 episodes of erysipelas in the same limb during a 1-year period defines recurrent erysipelas requiring prophylaxis. Such prophylaxis is based usually on penicillin therapy. Compression was evaluated only in a monocentric randomized controlled trial, and was never compared to antibioprophylaxis.

The investigators hypothesized that compression therapy alone might represent a single intervention for prophylaxis of erysipelas recurrence as efficient as long-term antibiotic prophylaxis with compression therapy combined.

This study is a multicenter, parallel groups, assessor-blinded, non-inferiority, randomized clinical trial. Main objective is to evaluate whether supervised compression therapy alone is non-inferior to supervised compression therapy + oral penicillin in controlling relapse of recurrent erysipelas. Secondary objectives are to assess time to first recurrence ; to assess the severity of the recurrence ; to assess the safety of the intervention to assess the quality of life during the prophylaxis phase ; to assess the adherence of patients with the intervention and to...

Conditions: Recurrent Erysipelas

Interventions: elastic stockings, Phenoxymethylpenicillin

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Last updated

Classification

Agency
NIH
Published
April 24th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial conduct Prophylaxis protocol research Lymphatic disease study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals Public Health

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