Clinical Trials Register

Summary
EudraCT Number:	2016-002249-53
Sponsor's Protocol Code Number:	P150924
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2023-01-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2016-002249-53

A.3

Full title of the trial

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

Traitement oral court de l’érysipèle par amoxicilline: essai contrôlé randomisé de non infériorité

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

SHort course of Amoxicilline for eRysipElas

Traitement court de l'érysipèle par l'amoxicilline

A.3.2

Name or abbreviated title of the trial where available

SHARE II

A.4.1

Sponsor's protocol code number

P150924

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Assistance Publique - Hôpitaux de Paris (AP-HP)
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministry of Health
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Assistance Publique - Hôpitaux de Paris
B.5.2	Functional name of contact point	DRCI - Hôpital Saint Louis
B.5.3	Address:
B.5.3.1	Street Address	1 avenue Claude Vellefaux
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75010
B.5.3.4	Country	France
B.5.4	Telephone number	33144841751
B.5.5	Fax number	33144841701
B.5.6	E-mail	france.guyot@aphp.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Amoxicillin 500 mg
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amoxicillin
D.3.9.1	CAS number	26787-78-0
D.3.9.4	EV Substance Code	SUB05481MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Adults diagnosed with lower limbs erysipelas/ cellulitis

Adultes ayant un érysipèle/dermohypodermite bactérienne des membres inférieurs.

E.1.1.1

Medical condition in easily understood language

Adults diagnosed with lower limbs erysipelas

Adulte ayant un Erysipèle des membres inférieures

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10037632
E.1.2	Term	Pyoderma
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Démontrer la non infériorité d’un traitement court oral (5 jours) d’amoxicilline 50 mg/kg par rapport aux 10 jours de traitement habituel pour la guérison de l’érysipèle à la fin du traitement à J12 (+/- 2), confirmée par un comité d’experts indépendants en aveugle du bras de traitement, à partir des photographies et données cliniques.

E.2.2

Secondary objectives of the trial

1) To compare the rate of clinical remission
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

1. Comparer le taux de rémission clinique de l’érysipèle
2. Comparer le taux et le nombre de patients sans antibiothérapie complémentaire pour dermohypodermite bactérienne
3. Comparer le taux de récidive à J28 +/-2.
4. Comparer le taux d’effets secondaires et indésirables dans les groupes de patients traités
5. Comparer le taux de rémission clinique de l’érysipèle à J7 +/- 2

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients ≥ 18 years
• Affiliated to a social security scheme
• 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
• 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
• Severity score ≥ 3 scored on three criteria: edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe)
• Absence of erysipelas ≤ 12 mois
• Absence of blisters
• Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)
• Absence of cutaneous necrosis
• Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema

• Patients ≥ 18 ans
• Affilié à un régime de sécurité sociale ou bénéficiaire (hors AME)
• Ayant signé un consentement libre et éclairé après avoir reçu une information complète sur le protocole.
• Signes cliniques d’érysipèles des membres inférieurs ≤ 5 jours définis par l’association de : chaleur, érythème œdème (induration des tissus cutanés et sous cutanés) et/ou douleur (EVA ≤8)
• Frissons, sensation fébrile ou fièvre ressentie par le patient dans un délai ≤ 5 jours ou fièvre mesurée par le médecin ≥ 38° C
• Score de sévérité ≥ 3, calculé sur 3 critères : œdème, érythème et douleur selon l’échelle suivante (0= aucun, 1=modéré, 2=sévère)
• Absence d’érysipèle ≤ 12 mois
• Absence de bulle
• Absence de purpura massif (nappe violette ne s’effaçant pas à la vitro pression)
• Absence de nécrose cutanée
• Absence de crépitation (crépitation= perception identique à celle d’un emphysème cutané)

E.4

Principal exclusion criteria

• Allergy to ß lactam, fructose intolerance
• Weight < 40 kg or >120 kg
• Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)
• Dermohypodermitis requiring hospitalization
• Erysipelas bilateral
• Abscess
• 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 biomedical drug research
• Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study

• Allergie aux ß lactamines, intolérance au fructose
• Poids < 40 kg ou >120 kg
• Prise orale d’antibiotiques dans les 5 jours (à l’exclusion d’une ou deux prises d’antibiotique ≤ 24 heures)
• Dermohypodermite nécessitant une hospitalisation
• Erysipèle bilatéral
• Abcès
• Lymphœdème nécessitant port permanant d’une contention
• Morsure animale ≤ 7 jours
• Patient séropositif par le HIV
• Patient présentant une comorbidité : Hépatite active connue, insuffisance rénale chronique ou insuffisant hépato-cellulaire
• Patient dans l’impossibilité d’interrompre un traitement au long court par antibiotique ou corticostéroïdes ou AINS
• Traitement anti-cancéreux, immunothérapie ou immunosuppresseurs ≤ 6 mois
• Femmes enceintes ou allaitantes
• Patient sous tutelle ou curatelle, sous protection juridique ou sous sauvegarde de justice
• Participation à une autre recherche interventionnelle
• Tout antécédent mental, psychologique ou psychiatrique compromettant la compréhension de l’essai et son déroulement en cas d’inclusion

E.5 End points

E.5.1

Primary end point(s)

Taux de rémission complète à la fin du traitement oral (à J12+/-2). La résolution complète est définie par :
1/ la disparition des symptômes : fièvre (T°≥ 38°) ET douleur, chaleur, œdème et érythème au site de l’érysipèle avec score de sévérité inférieur ou égale à 1,
2/ absence d’une nouvelle ligne d’antibiothérapie pour dermohypodermite bactérienne

Rate of complete remission (at day 12+/-2) 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

E.5.1.1

Timepoint(s) of evaluation of this end point

12 days after randomization

12 jours après la randomisation

E.5.2

Secondary end point(s)

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 J12 and J28+/-2.
4) Rate of adverse event during the treatment and the follow up periods as reported by the patient.
5) Rate of clinical remission at day 7 +/- 2: 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

1. Taux de rémission clinique de l’érysipèle : disparition de la fièvre (T≥38°) ET de la douleur, œdème ou érythème avec score de sévérité inférieur ou égale à 1 à J12+/- 2
2. Taux et nombre de patients ne recevant pas d’antibiothérapie complémentaire pour dermohypodermite bactérienne à J 12 +/- 2.
3. Taux de récidive défini par la nécessité d’une prolongation de l’antibiothérapie entre J12 et J28 +/-2.
4. Taux d’effets secondaires ou indésirables dans les deux groupes de patients pendant la période de traitement et de suivi.
5. Taux de rémission clinique de l’érysipèle : disparition de la fièvre (T≥38°) ET de la douleur, chaleur, œdème ou érythème avec score de sévérité inférieur ou égale à 1, sans recevoir d’antibiothérapie complémentaire à J7 +/- 2.

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days after randomization

28 jours après la randomisation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Traitement oral par amoxicilline à 50 mg/kg/jour pendant 10 jours

oral amoxicillin (50 mg/kg/j) for 10 days

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

550

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

106

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

656

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Aucun

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-08

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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