Clinical Trials Register

Summary
EudraCT Number:	2017-001327-45
Sponsor's Protocol Code Number:	69HCL17_0226
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-09-19
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

2017-001327-45

A.3

Full title of the trial

A pilot study of Ceftobiprole diffusion in bone and joint, in patients with BIJ( bone and joint infection) undergoing hip or knee replacement.

Etude pilote de dosage du Ceftobiprole dans les infections ostéo-articulaires chez des patients infectés programmés pour une chirurgie de remplacement de prothèse de hanche ou de genou.

A.3.1

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

A pilot study of Ceftobiprole diffusion in bone and joint, in patients with BIJ( bone and joint infection) undergoing hip or knee replacement.

Etude pilote de dosage du Ceftobiprole dans les infections ostéo-articulaires chez des patients infectés programmés pour une chirurgie de remplacement de prothèse de hanche ou de genou.

A.4.1

Sponsor's protocol code number

69HCL17_0226

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	Basilea Pharmaceutica International AG
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	Dr Valérie Plattner
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	+334 72 40 68 40
B.5.5	Fax number	+334 72 11 51 90
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	MABELIO
D.2.1.1.2	Name of the Marketing Authorisation holder	BASILEA MEDICAL LTD
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	Ceftobiprole
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CEFTOBIPROLE
D.3.9.1	CAS number	209467-52-7
D.3.9.4	EV Substance Code	SUB25723
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.92 to 1.93
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

Bone or joint Infection

Infection ostéo-articulaire

E.1.1.1

Medical condition in easily understood language

Bone or joint Infection

Infection ostéo-articulaire

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	10031252
E.1.2	Term	Osteomyelitis
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

Etude de la diffusion du ceftobiprole dans l’os et l’articulation.

E.2.2

Secondary objectives of the trial

Evaluation de la tolérance au ceftobiprole

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Homme ou femme âgés de plus de 18 ans
- Patient(e) ayant une infection ostéo articulaire documentée à Enterobactérie ou autre bactérie sensible au ceftobiprole
- Patient(e) devant être mis sous antibiothérapie pour leur infection
- Bactérie sensible au Ceftobiprole (antibiogramme réalisé lors de la prise en charge initiale)
- Patient programmé pour une chirurgie de remplacement de prothèse de hanche ou de genou (chirurgie en deux temps)

E.4

Principal exclusion criteria

- Patient(e) ayant une allergie suspectée ou connue aux β Lactamines
- Patient(e) ayant une hypersensibilité connue aux antibiotiques de la classe des céphalosporines.
- Patient(e) Infecté(e) par une bactérie résistante au Ceftobiprole
- Patient(e) présentant une insuffisance rénale définie par une clairance de la créatinine < à 50ml/min
- Patient(e) présentant une clairance de la créatinine supra-normale (> 150 ml/min),
- Patient(e) sous traitement par statines (pitavastatine, pravastatine, rosuvastatine) et/ou glibenclamide (DAONIL®) et/ou bosentan
- Personne refusant de participer à l’étude ou n’ayant pas signé le consentement éclairé
- Femmes enceintes, parturientes ou mères allaitantes
- Personnes privées de liberté par une décision judiciaire ou administrative, personnes faisant l'objet de soins psychiatriques, personnes admises dans un établissement sanitaire ou social à d'autres fins que celle de la recherche
- Patients mineurs
- Personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement
- Patient non affilié à un régime de sécurité sociale
- Patient participant à une autre recherche interventionnelle

E.5 End points

E.5.1

Primary end point(s)

Mesure des concentrations de ceftobiprole dans le sang, dans l’os cortical et spongieux, dans le fluide synovial, durant la chirurgie programmée.

E.5.1.1

Timepoint(s) of evaluation of this end point

D0 (Between 1 and 6 hour(s) after ceftobiprole infusion (during surgery))

J0 (entre 1h et 6h après la perfusion de ceftobiprole (durant la chirurgie programmée)

E.5.2

Secondary end point(s)

Recueil des événements indésirables graves et non graves durant la période de l’étude.

E.5.2.1

Timepoint(s) of evaluation of this end point

D-3 ; D-2 ; D-1 ; D0 ; D30

J-3 ; J-2 ; J-1 ; J0 ; J30

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

E.6.4

Safety

Yes

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

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.8.3

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

LVLS

Derniere visite dernier patient

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-09-19.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

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

2017-08-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-04

P. End of Trial
P.	End of Trial Status	Ongoing

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