Clinical Trials Register

Summary
EudraCT Number:	2015-001566-26
Sponsor's Protocol Code Number:	BDG-ETHIC
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-09-06
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001566-26

A.3

Full title of the trial

A B-D-GLUCAN DRIVEN ANTIFUNGAL STEWARDSHIP APPROACH TO MANAGE EMPIRICAL THERAPY IN PATIENTS AT VERY HIGH RISK FOR INVASIVE CANDIDIASIS: A RANDOMIZED CONTROLLED TRIAL

Una strategia di governo della terapia antifungina guidata da determinazioni seriate del BETA-D-GLUCANO (BDG) in una popolazione di pazienti ad alto rischio per candidiasi invasiva: studio controllato randomizzato

A.3.1

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

A B-D-GLUCAN DRIVEN ANTIFUNGAL STEWARDSHIP APPROACH TO MANAGE EMPIRICAL THERAPY IN PATIENTS AT VERY HIGH RISK FOR INVASIVE CANDIDIASIS: A RANDOMIZED CONTROLLED TRIAL

A.3.2

Name or abbreviated title of the trial where available

BDG-ETHIC

A.4.1

Sponsor's protocol code number

BDG-ETHIC

A.5.4

Other Identifiers

Name:

BDG-ETHIC

Number:

BDG-ETHIC

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	AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
B.1.3.4	Country	Italy
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	AOU di Bologna (fondi per la ricerca)
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AOU di Bologna
B.5.2	Functional name of contact point	U.O. Malattie Infettive - Prof.Vial
B.5.3	Address:
B.5.3.1	Street Address	Via Massarenti 9
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	0512143353
B.5.5	Fax number	051343500
B.5.6	E-mail	pierluigi.viale@unibo.it

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	TYGACIL - 50 MG POLVERE PER SOLUZIONE PER INFUSIONE 10 FLACONCINI DI VETRO 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH EUROPA LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	TYGACIL
D.3.2	Product code	TYGACIL
D.3.4	Pharmaceutical form	Powder 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	TIGECICLINA
D.3.9.2	Current sponsor code	TIGECICLINA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	MERREM - 500 MG POLVERE PER SOLUZIONE INIETTABILE PER USO ENDOVENOSO 10 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	merrem
D.3.2	Product code	merrem
D.3.4	Pharmaceutical form	Powder for solution for injection
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	MEROPENEM TRIIDRATO
D.3.9.2	Current sponsor code	meropenem
D.3.9.3	Other descriptive name	meropenem
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	TAZOCIN - 4 G + 0.500 G POLVERE PER SOLUZIONE PER INFUSIONE 12 FLACONCINI DI POLVERE
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Tazocin
D.3.2	Product code	tazocin
D.3.4	Pharmaceutical form	Powder 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	PIPERACILLINA SODICA
D.3.9.2	Current sponsor code	piperacillina
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAZOBACTAM SODICO
D.3.9.2	Current sponsor code	tazobactam
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 4
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	CANCIDAS - 50 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE ENDOVENOSA 1 FLACONCINO 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP e DOHME LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	cancidas
D.3.2	Product code	cancidas
D.3.4	Pharmaceutical form	Powder 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	CASPOFUNGIN DIACETATE
D.3.9.2	Current sponsor code	caspofungin
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 5
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	ECALTA - 100 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO-FLACONCINO (VETRO) DA 30 ML 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	ecalta
D.3.2	Product code	ecalta
D.3.4	Pharmaceutical form	Powder 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	ANIDULAFUNGINA
D.3.9.2	Current sponsor code	anidulafungina
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 6
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	AMBISOME - 50 MG POLVERE PER SOLUZIONE PER INFUSIONE 10 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	GILEAD SCIENCES S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	ambisome
D.3.2	Product code	ambisome
D.3.4	Pharmaceutical form	Powder 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	AMFOTERICINA B LIPOSOMAL
D.3.9.2	Current sponsor code	AMFOTERICINA b
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

invasive candidiasis

candidiasi invasiva

E.1.1.1

Medical condition in easily understood language

invasive candidiasis

candidiasi invasiva

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	LLT
E.1.2	Classification code	10064954
E.1.2	Term	Invasive candidiasis
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

demonstrate the possibility of a reduction in the duration of empiric antifungal therapy in patients with complicated surgical abdominal pathology and severe sepsis or septic shock framework through a management strategy based on seriata determination of serum levels of BDG, without a negative impact on the evolution of the clinical patient in terms of raw and duration of stay in hospital ICU mortality.

dimostrare la possibilità di una riduzione della durata di terapia antifungina empirica in pazienti con patologia addominale chirurgica complicata e quadro di sepsi grave o shock settico mediante una strategia gestionale basata sulla determinazione seriata dei livelli sierici di BDG, senza un impatto negativo sull’evoluzione clinica del paziente in termini di mortalità cruda e durata degenza di terapia intensiva.

E.2.2

Secondary objectives of the trial

1) demonstrate the accuracy of serial determinations of the BDG in the diagnosis of IC in patients with complicated surgical abdominal pathology and framework of severe sepsis or septic shock;
2) describe the kinetics of the BDG in relation to the treatment in a cohort of patients at high risk for ICs, differentiating on the basis of the state of colonization, infection and no event associated with Candida spp ..

1) dimostrare l’accuratezza di determinazioni seriate del BDG nella diagnosi di CI in pazienti con patologia addominale chirurgica complicata e quadro di sepsi grave o shock settico;
2) descrivere la cinetica del BDG in rapporto al trattamento in una coorte di pazienti ad alto rischio per CI, differenziandola in base a stato di colonizzazione, infezione e nessun evento associato a Candida spp..

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a. adult (= 18 year) patients;
b. severe sepsis or septic shock;
c. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.

• Pazienti adulti (età = 18 anni);
• Pazienti con una o più delle seguenti patologie al momento dell'arruolamento: i) peritonite post-chirurgica, ii) perforazioni gastrointestinali ricorrenti, iii) pancreatite necrotico-emorragica, iv) ascessi addominali post-chirurgici, e v) complicanze biliari post-chirurgiche o neoplastiche.
• Pazienti con criteri di sepsi grave/shock settico in accordo alle ultime linee guida internazionali del Surviving Sepsis Campaign (9).

E.4

Principal exclusion criteria

confirmed diagnosis of invasive candidiasis at enrollment;
• Exposure to antifungal therapy in the last 30 days prior to enrollment;
• Women who are pregnant and breastfeeding women;
• Known or suspected hypersensitivity to any of the antifungal drugs used in the protocol (echinocandins, amphothericina B liposomal);
• immunocompromised patients, one or pià of the following conditions: i) neutropenia (<0.5 × 109 neutrophils / L [<500 neutrophils / mm 3] for more than 10 days), ii) of allogeneic bone marrow transplantation, iii) congenital immunodeficiency (eg. chronic granulomatous disease, severe combined immunodeficiency), iv) HIV infection with CD4 + T lymphocyte count <200 / mmc.
• Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
• Use of experimental drugs in the last 30 days prior to study entry;
• Patients unable to follow the procedures of the Protocol and to sign the informed consent at the time of the pre-surgical evaluation.
• Women of childbearing potential not using effective contraception during treatment mechanical method.

• Diagnosi accertata di candidiasi invasiva al momento dell’arruolamento;
• Esposizione a terapia antifungina negli ultimi 30 giorni prima dell'arruolamento;
• Donne in gravidanza e donne in allattamento;
• Nota o sospetta ipersensibilità ad uno dei farmaci antifungini utilizzati nel protocollo (echinocandine, amphothericina B liposomiale);
• Pazienti immunodepressi, una o pià delle seguenti condizioni: i) neutropenia (<0.5 × 109 neutrofili/L [<500 neutrofili/mm3] per oltre 10 giorni), ii) trapianto di midollo osseo allogenico, iii) immunodeficienza congenita (es. malattia granulomatosa cronica, immunodeficienza combinata grave), iv) infezione da HIV con conta linfociti T CD4+ < 200/mmc.
• Pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindichino la partecipazione del paziente allo studio;
• Utilizzo di farmaci sperimentali negli ultimi 30 giorni prima dell’inclusione nello studio;
• Pazienti non in grado di seguire le procedure previste dal protocollo e di firmare il consenso informato al momento della valutazione pre-chirurgica.
• Donne in età fertile che non facciano uso di un metodo contraccettivo efficace meccanico durante il trattamento.

E.5 End points

E.5.1

Primary end point(s)

- duration of antifungal empirical therapy

- durata della terapia antifungina empirica

E.5.1.1

Timepoint(s) of evaluation of this end point

one month

un mese

E.5.2

Secondary end point(s)

28-day mortality, duration of hospitalization in intensive care units
- Sensitivity, specificity, positive predictive value and negative predictive value for the diagnosis of invasive candidiasis of baseline and seriated BDG. The outcome of cultures (blood culture, or intraoperative samples obtained by invasive procedures) will be considered the reference standard according to the definition of invasive candidiasis above.
- Kinetics of BDG in colonized patients, infected and no Candida spp related events.
- Incidence of invasive candidiasis within 3 months after discontinuation of antifungal empirical therapy

- mortalità a 28 giorni, durata degenza in unità di terapia intensiva
- sensibilità, specificità, valore predittivo positivo e valore predittivo negativo per la diagnosi di candidiasi invasiva di valori basali e seriati di BDG. L’esito degli esami colturali (emocolture, campioni intraoperatori o ottenuti da procedure invasive) sarà considerato lo standard di riferimento in accordo alla definizione di candidiasi invasiva riportata sopra.
- cinetica del BDG nei pazienti colonizzati, infetti e senza eventi correlati a Candida spp.
- incidenza di candidiasi invasiva entro 3 mesi dalla sospensione della terapia antifungina empirica

E.5.2.1

Timepoint(s) of evaluation of this end point

90 days

90 giorni

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

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

strategia BDG guidata verso strategia standard

BDG driven atifungal approach versus standard approach

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.8.5.1

Number of sites anticipated in the EEA

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

Information not present in EudraCT

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

120

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

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

180

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)

Normal patient care

Normale percorso assistenziale

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

2016-11-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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