PRESENT - Prophylaxis of Recurrent Erysipelas in lower limbs: compreSsion thErapy vs aNTibiotics and compression therapy. A non-inferiority, randomized, multicenter clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate whether the supervised compression therapy only is non-inferior to the supervised compression therapy + antibiotics in controlling relapse of recurrent erysipelas.

Secondary objectives 6

1. To assess time to the first confirmed recurrence of erysipelas.
2. To assess the severity of the recurrence.
3. To assess the safety of interventions.
4. To assess the quality of life during the prophylaxis phase.
5. To assess the adherence of patient to interventions.
6. To assess, in a joint analysis, that supervised compression therapy is both not inferior in terms of QALY and not more expensive at 1 year than supervised compression therapy + antibiotic.

Conditions and MedDRA coding

Recurrent Erysipelas in lower limbs

Study design 8 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male or female
2. ≥ 18 years of age
3. At least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization
4. The last recurrent erysipelas have to be diagnosed within the previous 3 months
5. BMI < 40 kg/m2 (no morbid obesity)
6. Able to apply the compression alone or with a helper (e.g., nurse, household member)
7. Affiliated with a social security regimen
8. Able to consent and written informed consent obtained from the participant
9. Able to understand the aims of the study and to comply with the requirements of the study
10. Able to participate and be followed up during the study period

Exclusion criteria 9

1. Any causes of immunosuppression: known HIV+ infection, organ transplantation, bone-marrow transplantation, immunosuppressive regimens for any disease, malignancy or lymphoproliferative disorder
2. Receiving antibiotic treatment for erysipelas
3. Received antibiotic prophylaxis for recurrent erysipelas in the year before randomization
4. Already wore effective compression therapy (worn at least 5 days a week) in the 3 months before randomization
5. Contraindication to compression therapy (ie arterial occlusive disease, heart failure)
6. History of known hypersensitivity to beta lactamines
7. Woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion in all women from 15 to 45 years old who have not had an ovariectomy.
8. Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).
9. Participation in another interventional research with an investigational drug or medical device.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded.

Secondary endpoints 9

1. Time to the first confirmed recurrence of erysipelas.
2. Severity of recurrence: number of nights in hospital for cellulitis.
3. Presence of skin necrosis or ulceration.
4. Assessment of adverse effects and serious adverse effects during the prophylaxis phase.
5. Quality of life: Dermatology Life Quality Index and EQ-5D-5L
6. Adherence: number of days per week that compression was worn (using a patient book).
7. Assessment of oedema by circumferential measurements and using the truncated cone formula.
8. Number of days per week that antibiotics is taken (using a patient book)
9. Health-economic: Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (15%).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours Cedex 9

Postcode

37044

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

VAILLANT Loïc

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

VAILLANT Loïc

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications