Clinical Trials Register

Summary
EudraCT Number:	2017-000162-30
Sponsor's Protocol Code Number:	69HCL16_0728
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-03-30
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

2017-000162-30

A.3

Full title of the trial

Place de la scintigraphie au 99mTc-Leukoscan® dans la prise en charge diagnostique des suspicions d’endocardite infectieuse sur matériels

A.3.1

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

Place de la scintigraphie au 99mTc-Leukoscan® dans la prise en charge diagnostique des suspicions d’endocardite infectieuse sur matériels

A.3.2

Name or abbreviated title of the trial where available

PLEIM

A.4.1

Sponsor's protocol code number

69HCL16_0728

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	Hospices Civils de Lyon
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Hospices Civils de Lyon
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	Hospices Civils de Lyon
B.5.2	Functional name of contact point	Direction de la Recherche Clinique
B.5.3	Address:
B.5.3.1	Street Address	3 quai des Célestins
B.5.3.2	Town/ city	Lyon
B.5.3.3	Post code	69002
B.5.3.4	Country	France
B.5.4	Telephone number	478406818+33
B.5.5	Fax number	472115190+33
B.5.6	E-mail	drci_promo@chu-lyon.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.2.1.1.1	Trade name	LeukoScan
D.2.1.1.2	Name of the Marketing Authorisation holder	Immunomedics GmbH
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.3.4	Pharmaceutical form	Powder for concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

sujets adultes présentant une suspicion clinique d’endocardite infectieuse sur valve prothétique ou d’infection sur dispositif implantable cardiaque.

E.1.1.1

Medical condition in easily understood language

sujets adultes présentant une suspicion clinique d’endocardite infectieuse sur valve prothétique ou d’infection sur dispositif implantable cardiaque.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10014678
E.1.2	Term	Endocarditis infective
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

évaluer les performances diagnostiques (sensibilité, spécificité, valeur prédictive positive et négative) de la scintigraphie au 99mTc-Leukoscan dans la recherche d’infection sur valve prothétique ou sur dispositif implantable cardiaque

E.2.2

Secondary objectives of the trial

- Comparer les performances diagnostiques de la scintigraphie au 99mTc et celle de l’échographie transoesophagienne chez les patients présentant une suspicion d’endocardite infectieuse sur matériels.
- Evaluer si la scintigraphie au 99mTc-Leukoscan permet d’apporter un complément diagnostique chez les patients présentant une suspicion d’endocardite infectieuse sur matériels et ayant une échographie trans-oesophagienne non contributive.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patient majeur de plus de 21 ans.
• Patients présentant une suspicion clinique d’infection sur valve prothétique ou d’infection sur dispositif implantable cardiaque à l’hôpital Louis Pradel des Hospices Civils de Lyon
• Patient affilié à / ou bénéficiaire d’un régime de Sécurité Sociale tel que défini par la loi
• Patients volontaires pour leur participation à l’étude ayant compris l’objectif de l’étude décrit dans le formulaire dédié qu’ils ont signé : Consentement libre, éclairé et écrit, signé par le patient

E.4

Principal exclusion criteria

• Patient aux antécédents d’exposition à des antigènes murins en particulier patient ayant déjà bénéficié d’une scintigrpahie au 99mTc-Leukoscan®
• Patients dont l’état clinique nécessite une prise en charge rapide ne permettant pas d’attendre la réalisation des examens
• Grossesse et allaitement
• Patients sous antibiothérapie adaptée depuis plus de 15 jours
• Privation de droits civils (curatelle, tutelle, sauvegarde de justice)

E.5 End points

E.5.1

Primary end point(s)

Présence ou non d’une EI sur matériels (valve prothétique ou dispositif implantable cardiaque).
Le gold standard sera basé sur le suivi à 3 mois (+/-1 mois) avec décision concertée de la réunion de concertation pluridisciplinaire sur l’EI de l’Hôpital cardiologique tenant compte selon la pratique courante, de l’ensemble des éléments clinico-biologiques, bactériologiques et de l’imagerie, à l’exclusion des résultats de la scintigraphie au 99mTc- Leukoscan.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 mois

E.5.2

Secondary end point(s)

Présence ou non d’une infection sur valve prothétique ou sur dispositif implantable cardiaque.
Le gold standard sera basé sur le suivi à 3 mois (+/-1 mois) avec décision concertée de la réunion de concertation pluridisciplinaire sur l’endocardite infectieuse de l’Hôpital cardiologique tenant compte selon la pratique courante, de l’ensemble des éléments clinico-biologiques, bactériologiques et de l’imagerie, à l’exclusion des résultats de la scintigraphie au 99mTc- Leukoscan®.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 mois

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-03-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-06

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