Clinical Trials Register

Summary
EudraCT Number:	2012-005699-33
Sponsor's Protocol Code Number:	12-179
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-09-25
Trial results	View 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

2012-005699-33

A.3

Full title of the trial

Etude de la pharmacocinétique de la daptomycine en administration intrapéritonéale chez les patients en dialyse péritonéale présentant une infection péritonéale.

A.3.1

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

DAPTOMYCINE et INFECTION PERITONEALE pour les patients en dialyse péritonéale

A.3.2

Name or abbreviated title of the trial where available

DAPTO DP

A.4.1

Sponsor's protocol code number

12-179

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	CHU Caen
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	CHU CAEN
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	CHU Caen
B.5.2	Functional name of contact point	LOBBEDEZ
B.5.3	Address:
B.5.3.1	Street Address	Service de néphrologie, CHU CAEN
B.5.3.2	Town/ city	CAEN
B.5.3.3	Post code	14033
B.5.3.4	Country	France
B.5.4	Telephone number	33231272024
B.5.5	Fax number	33231065068
B.5.6	E-mail	lobbedez-t@chu-caen.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	CUBICIN
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraperitoneal use
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

renal failure

insuffisance rénale

E.1.1.1

Medical condition in easily understood language

renal failure

insuffisance rénale

E.1.1.2

Therapeutic area

Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10067594
E.1.2	Term	Peritoneal dialysis complication
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

concentration intrapéritonéale > 16 mg/L pendant 6h tous les jours (oui/non)

E.2.2

Secondary objectives of the trial

concentrations plasmatiques >16mg/L pendant au moins 2 heures tous les jours
concentration maximale plasmatique < 120 mg/L tous les jours
concentration plasmatique résiduelle < 25mg/L tous les jours
tolérance de la daptomycine en intra-péritonéale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patient de plus de 18 ans en dialyse péritonéale présentant une infection péritonéale suspectée (liquide de dialyse trouble et Bandelette Réactive Urinaire positive du liquide de dialyse péritonéale) avec résultat d’examen direct du liquide de dialyse péritonéale positif à gram positif ou résultat négatif et qui nécessitera une hospitalisation
Patient en dialyse péritonéale depuis au moins 3 mois
Patient ayant signé un consentement éclairé
Patient ayant une espérance de vie supérieure à 6 mois

E.4

Principal exclusion criteria

résultat d’examen direct du liquide de dialyse péritonéale positif à gram négatif
Patient présentant des contre-indications à la daptomycine (cf RCP Cubicin® : hypersensibilité)
Patient déjà traité par antibiotiques, antifongiques dans les 4 semaines ayant précédé l’événement
Patient présentant une insuffisance hépatique (score Child Pugh C)
Patient présentant des arguments pour un foyer infectieux extra-péritonéal (des hémocultures seront réalisées pendant l’étude)
Patient présentant une hypersensibilité à la vancomycine
Hypersensibilité à la ceftazidime, à toute autre céphalosporine ou à l’un des excipients. Antécédents d’hypersensibilité grave (par exemple réaction anaphylactique) à tout autre type de produit antibactérien de la famille des béta-lactamines (pénicillines, monobactames ou carbapénèmes)
Patient présentant une pathologie intercurrente sévère (ex : hémopathie maligne, patient sous chimiothérapie)
Patient avec symptômes musculaires et CPK>5 UNL
Patient ne pouvant donner seul son consentement
Femme enceinte ou allaitante
Patient cirrhotique

E.5 End points

E.5.1

Primary end point(s)

Mesure de la concentration intrapéritonéale en daptomycine à la fin de l’infusion, permettant de vérifier que la pharmacocinétique répond à l’objectif principal de l’étude : Concentration intrapéritonéale à H6 >16mg/L

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

Concentrations intrapéritonéales à H0, H6, aux deux autres temps des changements de poches et à H24 de J1 et J5
Concentrations plasmatiques à H0, H0.5, H1, H2, H4, H6, aux deux autres temps des changements de poches et à H24 de J1 et J5
Concentration plasmatique H0 J15 ou J22
Concentration/Volume des urines de 24H de J1 et J5
Surveillance des signes cliniques d’infection péritonéale, des résultats d’hémoculture à J3 et J15 ou 22 et des analyses bactériologiques et cytologiques des prélèvements du liquide de dialyse à J3 et J15 ou 22 pour vérifier l’efficacité antibiotique.
Surveillance de la tolérance par le recueil des EI/EIG

E.5.2.1

Timepoint(s) of evaluation of this end point

H0 à J22

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

E.6.6

Pharmacokinetic

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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.8.3

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

J21

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	12
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	12

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

2013-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-09-04

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