Clinical Trials Register

Summary
EudraCT Number:	2018-001505-90
Sponsor's Protocol Code Number:	18CH049
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:	2018-06-28
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

2018-001505-90

A.3

Full title of the trial

Decolonization of patients carrying S. aureus before cardiac surgery: study of the risk factors associated with failure

Décolonisation des patients porteurs de Staphylococcus aureus en chirurgie cardiaque : étude des facteurs de risque d’échec de décolonisation

A.3.1

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

Decolonization of patients carrying S. aureus before cardiac surgery: study of the risk factors associated with failure

Décolonisation des patients porteurs de Staphylococcus aureus en chirurgie cardiaque : étude des facteurs de risque d’échec de décolonisation

A.3.2

Name or abbreviated title of the trial where available

STAdécol

A.4.1

Sponsor's protocol code number

18CH049

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 de Saint Etienne
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 de Saint Etienne
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 de Saint Etienne
B.5.2	Functional name of contact point	Project manager
B.5.3	Address:
B.5.3.1	Street Address	URCIP Hôpital Nord
B.5.3.2	Town/ city	SAINT ETIENNE CEDEX 2
B.5.3.3	Post code	42055
B.5.3.4	Country	France
B.5.4	Telephone number	0477829272+33
B.5.5	Fax number	0477127820+33
B.5.6	E-mail	marie.peuriere@chu-st-etienne.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	bactroban
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoire GLAXOSMITHKLINE
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	mupirocine
D.3.4	Pharmaceutical form	Nasal ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasal 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)	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.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	hextril
D.2.1.1.2	Name of the Marketing Authorisation holder	JOHNSON & JOHNSON SANTE BEAUTE 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	héxétidine
D.3.4	Pharmaceutical form	Mouthwash
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	No
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.IMP: 3
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	hibiscrub
D.2.1.1.2	Name of the Marketing Authorisation holder	Regent Medical Overseas Limited
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	digluconate de chlorhexidine
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous 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)	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

Decolonization of S. aureus nasal carriers before cardiac surgery

Décolonisation des porteurs nasaux de S. aureus avant la chirurgie cardiaque

E.1.1.1

Medical condition in easily understood language

Decolonization of S. aureus nasal carriers before cardiac surgery

Décolonisation des porteurs nasaux de S. aureus avant la chirurgie cardiaque

E.1.1.2

Therapeutic area

Body processes [G] - Microbiological Phenomena [G06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10075981
E.1.2	Term	Staphylococcus aureus infection
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10048935
E.1.2	Term	Open heart surgery
E.1.2	System Organ Class	100000004865

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 identify the main risk factors for failure of pre-operative decolonization of S. aureus by antimicrobials in patients undergoing scheduled cardiac surgery.

Identifier les principaux facteurs de risque d’échec d'une décolonisation de S. aureus par antimicrobiens en pré-opératoire chez des patients bénéficiant d'une chirurgie cardiaque programmée.

E.2.2

Secondary objectives of the trial

1. Determine the prevalence of nasal carriage of S. aureus just prior to cardiac surgery
2. To evaluate the interest of mupirocin dosing in the nasal swab as an indicator of observance with mupirocin decolonization.
3. Evaluate the value of measuring the mupirocin metabolite (monic acid) in the urine
4. If decolonization fails, determine by molecular typing (AP-PCR and / or spa typing) whether it is a relapse (same strain) or a recurrence by a different strain.
5. In case of similarity of strains, determine the incidence of resistance acquisition in S. aureus strains (mupirocin and chlorhexidine).
6. Determine the prevalence of nasal carriage of S. aureus 3 months after cardiac surgery

1. Déterminer la prévalence du portage nasal de S. aureus juste avant la chirurgie cardiaque
2. Evaluer l’intérêt du dosage de mupirocine dans le prélèvement nasal comme indicateur de l’observance de la décolonisation par mupirocine.
3. Evaluer l’intérêt du dosage du métabolite de la mupirocine (acide monique) dans les urines
4. En cas d’échec de la décolonisation, déterminer par typage moléculaire (AP-PCR et/ou spa typing) s’il s’agit d’une rechute (même souche) ou d’une récidive par une souche différente.
5. En cas de similitude des souches, déterminer l’incidence d’acquisition de résistance chez les souches de S. aureus (mupirocine et chlorhexidine).
6. Déterminer la prévalence du portage nasal de S. aureus 3 mois après la chirurgie cardiaque

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adult patients
- Scheduled cardiac surgery at the University hospital of Saint-Etienne
- primary surgery
- signature of consent

- Patient(e) majeur(e)
- Patient(e) devant bénéficier d’une chirurgie cardiaque programmée au CHU de Saint-Etienne
- Chirurgie de première intention (pas de reprise)
- Signature consentement de participation

E.4

Principal exclusion criteria

- Surgical site infection
- Surgery in an emergency and semi-emergency context
- patient under guardianship
- pregnancy

- Chirurgie dans un contexte d’infection
- Chirurgie dans un contexte d’urgence et de semi-urgence
- Patient sous tutelle
- Femme enceinte

E.5 End points

E.5.1

Primary end point(s)

Analysis of failures of decolonization of patients carrying S. aureus in their nose

l’échec de la décolonisation des porteurs nasaux de S. aureus

E.5.1.1

Timepoint(s) of evaluation of this end point

before surgery

avant la chirugie

E.5.2

Secondary end point(s)

1. Number of patients detected positive in culture for S. aureus just prior to cardiac surgery compared to the total number of patients included.

2. Correlation between nasal dosing of mupirocin (calculated in mg / L of nasal secretion) and observance.

3. Correlation between urinary metabolite dosage of mupirocin (calculated in mg / L of urine) associated with the nasal dosage of mupirocin and decolonization efficiency (failure or not).

4. In case of failure of decolonization, study of the similarity of strains isolated in the same patient before-after decolonization to differentiate recurrences of recurrence.

5. In case of strains similarity, proportion of S. aureus strains resistant to mupirocin or chlorhexidine to evaluate failures related to antimicrobial selection pressure.

6. Number of patients detected positive in culture for S. aureus 3 months after cardiac surgery compared to the total number of patients included.

1. nombre de patients détectés positifs en culture pour S. aureus juste avant la chirurgie cardiaque par rapport au nombre total de patients inclus.
2. Corrélation entre dosage nasal de mupirocine (calculé en mg/L de sécrétion nasale) et observance.
3. Corrélation entre dosage du métabolite urinaire de la mupirocine (calculé en mg/L d’urines) associé au dosage nasal de mupirocine et efficacité de décolonisation (échec ou non).
4. En cas d’échec de la décolonisation, étude de la similarité des souches isolées chez un même patient avant-après décolonisation pour différencier rechutes de récidive.
5. En cas de similitude des souches, proportion de souches de S. aureus résistantes à la mupirocine ou à la chlorhexidine pour évaluer les échecs liés à la pression de sélection des antimicrobiens.
6. Prévalence du portage nasal de S. aureus 3 mois après la chirurgie cardiaque chez l’ensemble des patients de l’étude, décolonisés ou non : nombre de patients détectés positifs en culture pour S. aureus 3 mois après la chirurgie cardiaque par rapport au nombre total de patients inclus.

E.5.2.1

Timepoint(s) of evaluation of this end point

before surgery

avant la chirugie

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

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

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.8.2.4

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

LVLS

dernier 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

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.1.3

Elderly (>=65 years)

Yes

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

600

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

2018-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-10

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