SHort course of Amoxicilline for eRysipElas II

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2024-11-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French Ministry of Health

External identifiers

EU CT number

2024-515306-61-00

EudraCT number

2016-002249-53

ClinicalTrials.gov

NCT07104552

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that a short course (5 days) of amoxicillin 50 mg/kg is not inferior to the usual course (10 days) to achieve complete erysipelas remission at day 12+/-2 confirmed by a central independent committee blinded adjudicated from the intervention received, using photos and clinical datas.

Secondary objectives 5

1. To compare the 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
2. To compare the rate and number of patients without additional antibiotherapy for cellulitis
3. To compare the rate of recurrence at day 28 +/-2.
4. To compare the rate of adverse events for the two strategies.
5. To compare the rate of complete remission at day 7 +/-2 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

Conditions and MedDRA coding

Adults diagnosed with lower limbs erysipelas

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Patients ≥ 18 years
2. Affiliated to a social security scheme
3. Who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements
4. Clinical signs of leg erysipelas ≤ 5 days defined by the association of : Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS≤8)
5. Shiver, feverish sensation or fever experienced by the patient ≤ 5 days or fever measured by the physician ≥ 38°C
6. Severity score ≥ 3 scored on three criteria : edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe)
7. Absence of erysipelas ≤ 12 mois
8. Absence of blisters
9. Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)
10. Absence of cutaneous necrosis
11. Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema

Exclusion criteria 16

1. Allergy to ß lactam, intolerance to fructose
2. Weight < 40 kg or > 105 kg
3. Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)
4. Dermohypodermitis requiring hospitalization
5. Erysipelas bilateral
6. Abscess
7. Lymphedema requiring permanent contention
8. Animal bite ≤ 7 days
9. HIV positive
10. Patient with comorbidity: known active hepatitis, chronic kidney failure or hepatocellular insufficiency
11. Patient unable to temporarily stop a long-term treatment as antibiotics or corticosteroids
12. Anti-cancer, immunotherapy or immunosuppressive therapy ≤ 6 months
13. Pregnant women or breastfeeding
14. Patient under guardianship or curatorship, legal protection or protection of justice
15. Participation in other Clinical Trial, interventional study, investigational study or performance study
16. Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 5

1. 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.
2. Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2
3. Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between day 12 and day 28+/- 2.
4. Rate of adverse event during the treatment and the follow up periods as reported by the patient.
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, without receiving additional antibiotherapy at day 7 +/- 2

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Tu Anh Duong

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Tu Anh Duong

Locations

1 EU/EEA country · 35 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 17 files

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

Application history

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