Clinical Trials Register

Summary
EudraCT Number:	2016-001576-30
Sponsor's Protocol Code Number:	15783408
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:	2016-11-15
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

2016-001576-30

A.3

Full title of the trial

Interest of Intra-nodal injection of gentamicin for the treatment of suppurated cat scratch disease’s lymphadenitis: a randomized controlled study.

"BIGG" : Bartonellosis and intra-nodal injection of gentamicin

Intérêt d’une injection intra-ganglionnaire de gentamicine dans le traitement des formes ganglionnaires suppurées de maladie des griffes du chat : étude contrôlée randomisée en double aveugle.

« BIGG » : Bartonellose et Injection intra-Ganglionnaire de Gentamicine

A.3.1

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

Suppurated cat scratch disease’s and intra-nodal injection of gentamicin

Maladie des griffes du chat et Injection intra-Ganglionnaire de Gentamicine

A.3.2

Name or abbreviated title of the trial where available

BIGG

A.4.1

Sponsor's protocol code number

15783408

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 TOULOUSE
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	GIRCI
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 TOULOUSE
B.5.2	Functional name of contact point	CLINICAL RESEARCH ASSISTANT
B.5.3	Address:
B.5.3.1	Street Address	Hôtel-Dieu 2 rue Viguerie TSA 80035
B.5.3.2	Town/ city	Toulouse
B.5.3.3	Post code	31059
B.5.3.4	Country	France
B.5.4	Telephone number	5 61 77 84 9033
B.5.5	Fax number	5 61 77 84 1133
B.5.6	E-mail	huguet.a@chu-toulouse.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	No
D.2.1.1.1	Trade name	Gentamicine
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires Panpharma SA
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	Gentamicine
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional 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	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.IMP: 2
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	Azithromycine
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER PFE FRANCE
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	ZITHROMAX 250mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral 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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intralesional use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bartonellosis

Bartonellose

E.1.1.1

Medical condition in easily understood language

Cat scratch disease’s

Maladie des griffes du chat

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10004145
E.1.2	Term	Bartonellosis
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

The aim is to assess the benefit of an intra-nodal injection at 28 days of gentamicin add-on oral azithromycin on the outcome of suppurated cat scratch disease’s lymphadenitis in adults.

Comparer l'effet d’une injection intra-ganglionnaire de gentamicine versus placebo sur l’évolution à 28 jours chez des patients ayant une MGC ganglionnaire suppurée traitée par azithromycine par voie orale.

E.2.2

Secondary objectives of the trial

• To compare the effect of gentamicine intra-nodal injection versus saline injection on :
-adenitis volume echographic evolution between day 0 and day 28
-evolution of the pain related to the adenitis evaluated by analogic visual scale between day 0 and day 28
-time with persisting cutaneous fistulization of the adenitis
-requirement supplementary needle pus evacuation
-requirement surgical excision or incision of the adenitis
-serum Protein C reactive level between day 0 and day 7
-genotypic profile of resistance to macrolides and aminoglycosides
-safety of the intra-nodal injection of gentamicin

• Comparer l'effet d’une injection intra-ganglionnaire de gentamicine versus placebo sur :
-L’évolution échographique du volume de l’adénopathie entre J0 et J28
-L’évolution de la douleur mesurée par échelle visuelle analogique
-La durée de fistulisation cutanée de l’adénite
-La nécessité de ponctions évacuatrices supplémentaires
-La nécessité d’une excision ou une incision chirurgicale
-L’évolution du taux sérique de C réactive protéine entre J0 et J7
-Profil génotypique de résistance de B. henselae aux macrolides et aux aminosides
-Sécurité de l’injection intra-ganglionnaire de gentamicine ou de placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adults > or = 18 years old
- Informed consent
- Suppurated CSD’s adenitis:
• Suppurated form of adenitis confirmed by echography
• Serology positive for IgG and/or IgM against B. henselae

- Majeur
- Consentement éclairé (et accord parental pour les mineurs)
- Forme ganglionnaire suppurée de MGC
• Adénite suppurée confirmée par échographie
• Sérologie Bartonella henselae positive en IgG et/ou IgM

E.4

Principal exclusion criteria

- Suppurated adenitis non related to CSD
- Non-suppurated CSD’s adenitis
- Suppurated CSD’s adenitis already fistulized
- Suspected visceral B. henselae infection (neurologic or ophthalmic symptoms, hepato-splenic or valvular involvement confirmed by echography)
- Immunodepression (except well equilibrated diabetes)
- Pregnancy or lactating women
- Contraindication to pus aspiration from lymphadenitis (history of bleeding or patient taking curative anticoagulation therapy or platelet count < 50.000/mm3)
- Contraindication to azithromycin (history of QT interval prolongation, history of liver toxicity of hypersensitivity to macrolides or treatment with ergotamine, dihyroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosids (myasthenia, history of hypersensitivity to aminoglycosides)

- Adénite suppurée d’une autre étiologie qu’une MGC
- MGC avec adénite non suppurée
- MGC avec adénite d’emblée fistulisée
- Bartonellose systémique évoquée devant des signes neurologiques (encéphalite), ophtalmologiques (rétinite), une atteinte hépato-splénique iconographique, ou endocardite échographique
- Patients sous anticoagulation curative ou présentant un trouble de l’hémostase contre-indiquant la ponction ganglionnaire (numération plaquettaire < 50000/mm3)
- Immunodépression (sauf diabète équilibré)
- Femme enceinte, allaitante
- Patient présentant une contre-indication à l’azithromycine (Allongement de l’espace QT congénital ou documenté, antécédents d’ictère cholestatique ou de dysfonctionnement hépatique ou hypersensibilité aux macrolides, patient sous ergotamine, dihydroergotamine, bepridil, cisapride, pimozide, mizolastine, colchicine) ou aux aminosides (myasthénie, antécédents d’hypersensibilité aux aminosides)
-Régime de protection juridique des majeurs

E.5 End points

E.5.1

Primary end point(s)

Frequency at day 28 of CSD’s adenitis unfavorable outcome, using a combined criterion that includes
o a reduction of the volume of the adenitis evaluated by echography of < 80% compared to day 0,
o and/or the requirement of supplementary needle aspirations between day 14 and day 28,
o and/or the requirement of a surgical excision or incision of the adenitis.

Le critère de jugement principal, mesuré à J28 en insu du groupe de traitement par le clinicien responsable du patient, sera la fréquence de l’évolution défavorable de la MGC sous la forme d’un critère combiné comprenant
• la réduction de <80% par rapport à J0 du volume de l’adénite mesurée par échographie,
• et/ou la nécessité de ponctions évacuatrices supplémentaires entre J14 et J28,
• et/ou ou la nécessité d’une excision/incision chirurgicale de l’adénite.

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 jours

E.5.2

Secondary end point(s)

- Percentage of volume reduction of the adenitis, evaluated by ultrasound between day 0 and day 28
- Percentage of reduction of the pain related to the adenitis evaluated by analogic visual scale between day 0, day 7 and day 28
- Percentage of patients with persisting cutaneous fistulization of the adenitis at day 7, day 14, day 21 and day 28
- Percentage of patients requiring supplementary needle pus evacuation between day 14 and day 28
- Percentage of patients requiring surgical excision or incision of the adenitis
- Percentage of decrease of serum Protein C reactive level between day 0 and day 7
- Genotypic profile of resistance to macrolides and aminoglycosides
- Safety of the intra-nodal injection of gentamicin

• Pourcentage de réduction entre J0 et J28 du volume de l’adénite mesurée par échographie
• Pourcentage de réduction entre J0, J7 et J28 de la douleur liée à l’adénite
• Pourcentage de patients ayant une fistulisation cutanée de l’adénite prolongée > 7 jours et > 28 jours
• Pourcentage de patients ayant nécessité des ponctions évacuatrices supplémentaires
• Nombre de ponctions évacuatrices supplémentaires par patient
• Pourcentage de patients ayant nécessité une excision ou une incision chirurgicale
• Pourcentage de réduction du taux sérique de C réactive protéine entre J0 et J7
• Profil génotypique de résistance de B. henselae aux macrolides et aux aminosides
• Sécurité de l’injection intra-ganglionnaire de gentamicine ou de placebo

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days

28 jours

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

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

dernière visite du 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

Yes

F.1.1

Number of subjects for this age range:

100

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

100

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

100

F.1.3

Elderly (>=65 years)

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 2016-11-15.

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

100

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)

When the subject has ended the participation in the trial, he is follow as usual practice

A la fin de la recherche, les patients sont pris en charge conformément à la pratique courante

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

2016-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-28

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

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