Clinical Trials Register

Summary
EudraCT Number:	2015-001900-76
Sponsor's Protocol Code Number:	PRASCO
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001900-76

A.3

Full title of the trial

Manipulating the microbiome in IBD by antibiotics and fecal microbiota transplantation (FMT): a randomized controlled trial

STUDIO PROSPETTICO, RANDOMIZZATO, CONTROLLATO SULL’EFFICACIA DI UNA TERAPIA ANTIBIOTICA COMBINATA NELLA COLITE ACUTA SEVERA PEDIATRICA

A.3.1

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

Use of antibiotics in children affected by acute colitis severe

Uso di una combinazione di antibiotici nel bambino affetto da colite acuta severa.

A.3.2

Name or abbreviated title of the trial where available

PRASCO

A.4.1

Sponsor's protocol code number

PRASCO

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	UMBERTO I - POLICLINICO DI ROMA
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	Shaare Zedek Medical Center
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dipartimento di Pediatria "Sapienza" Università di Roma/Azienda Policlinico Umberto I
B.5.2	Functional name of contact point	UOC di Gastroenterologia Pediatrica
B.5.3	Address:
B.5.3.1	Street Address	viale Regina Elena, 324
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00161
B.5.3.4	Country	Italy
B.5.4	Telephone number	0649979324
B.5.5	Fax number	0649979324
B.5.6	E-mail	gastropediatria@uniroma1.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	AMOXICILLINA MYLAN GENERICS - 5 G/100 ML POLVERE PER SOSPENSIONE ORALE FLACONE 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MYLAN 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	Amoxicillina
D.3.4	Pharmaceutical form	Powder and solvent for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMOXICILLINA TRIIDRATO
D.3.9.2	Current sponsor code	Amoxicillina
D.3.9.3	Other descriptive name	Amoxicillin
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
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: 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	BASSADO - 100 MG COMPRESSE 10 COMPRESSE
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	Doxiciclina
D.3.2	Product code	Doxiciclina
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DOXICICLINA ICLATO
D.3.9.2	Current sponsor code	Doxiciclina
D.3.9.3	Other descriptive name	doxycycline
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: 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	VANCOMICINA HOSPIRA - 1 G POLVERE PER SOLUZIONE ORALE PER INFUSIONE ENDOVENOSA 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	HOSPIRA 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	Vancomicina
D.3.2	Product code	Vancomicina
D.3.4	Pharmaceutical form	Powder and solvent for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VANCOMICINA CLORIDRATO
D.3.9.2	Current sponsor code	Vancomicina
D.3.9.3	Other descriptive name	vancomycin
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	FLAGYL - 250 MG COMPRESSE20 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ZAMBON 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	Flagyl
D.3.2	Product code	Metronidazolo
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METRONIDAZOLO
D.3.9.2	Current sponsor code	Metronidazolo
D.3.9.3	Other descriptive name	metronidazole
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	URBASON SOLUBILE - 250 MG/5 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE1 FIALA POLVERE + 1 FIALA SOLVENTE 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS 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	Urbason
D.3.2	Product code	Cortisone
D.3.4	Pharmaceutical form	Powder and solvent 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	METILPREDNISOLONE EMISUCCINATO SODICO
D.3.9.2	Current sponsor code	Cortisone
D.3.9.3	Other descriptive name	methylprednisolone
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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: 6
D.1.2 and D.1.3	IMP Role	Comparator
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	URBASON SOLUBILE - 250 MG/5 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE1 FIALA POLVERE + 1 FIALA SOLVENTE 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS 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	Urbason
D.3.2	Product code	Cortisone
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	METILPREDNISOLONE EMISUCCINATO SODICO
D.3.9.2	Current sponsor code	Cortisone
D.3.9.3	Other descriptive name	Methylprednisolone
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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

Acute Severe colitis

colite acuta severa

E.1.1.1

Medical condition in easily understood language

Acute Severe colitis

colite acuta severa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10045283
E.1.2	Term	UC aggravated
E.1.2	System Organ Class	100000004856

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 primary aim is to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy, in an open label, investigator-blinded, add-on randomized trial.

L’obiettivo di questo studio pilota è di valutare l’efficacia di una terapia antibiotica combinata in pazienti pediatrici sottoposti a terapia cortisonica endovenosa per colite severa (ASC e IBDU) in un trial randomizzato, “add-on”, open-label, investigator-blinded. Si paragoneranno 2 trattamenti: il primo gruppo riceverà antibiotici in aggiunta agli steroidi (gruppo “CS+AB”), mentre il secondo riceverà un trattamento steroideo (gruppo di terapia standard “CS”).

E.2.2

Secondary objectives of the trial

- Remission rates (defined by PUCAI<10) without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy, at days 7, separately at discharge, separately at day 14, and separately at 90 days.
- Number of patients with PUCAI<35 points at day 5, without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy.
- The need for second line therapy by discharge and by 90 days.
- Calprotectin levels at 5 and 14 days after treatment.
- Change in microbiome pattern.
- Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) at days 5 and 14 after treatment.
- Rate of C. difficile infection at days 5 and 14 after treatment.

Valutare:
-i tassi di remissione (definiti con un PUCAI<10) senza la necessità di ricorrere ad una terapia di seconda linea (anti-TNF, ciclosporina o tacrolimus) o a colectomia, al giorno 7, alla dimissione, al giorno 14, e a 90 giorni;
-il numero di pazienti con un PUCAI<35 al giorno 5,senza la necessità di ricorrere ad una terapia di seconda linea o a colectomia;
-la necessità di ricorrere ad una terapia di seconda linea o a colectomia alla dimissione, a 90 giorni e ad un anno;
-i livelli di calprotectina nei giorni 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento;
-le modificazioni del microbioma nei giorni 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento;
-la presenza di batteri resistenti a livello intestinale al giorno 10 e nei mesi 1, 2, 3, 6 e 12 dopo il trattamento;
-il tasso di incidenza di infezioni da C.difficile al giorno 10, e nei mesi 1, 2, 3, 6, 12 dopo il trattamento con analisi PCR.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Children between 6 and 18 years with established diagnosis of UC and IBDU using standard criteria (1, 2).
- Admission for IV steroid therapy
- PUCAI of at least 65 points at admission (i.e. severe attack)
- PUCAI>45 at enrolment
- Ability to swallow antibiotics (pills or syrup)

- Bambini di età compresa tra gli 6 e i 18 anni con diagnosi di UC stabilita con i criteri standard (24, 25) e IBD-U ricoverati per ricevere terapia steroidea endovenosa;
- PUCAI di almeno 65 al momento del ricovero;
- Capacità di assumere terapia orale;

E.4

Principal exclusion criteria

- Disease confined to the rectum (Proctitis).
- Antibiotic use for > 3 days in the past 2 weeks, or patients receiving antibiotics at enrollment.
- Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc.
- Fever >38.5, or >38.0c thought to be unrelated to the inflammatory process of active UC.
- The need for imminent surgery (peritoneal abdominal signs, toxic megacolon (3), massive bleeding etc).
- The probable need for second line medical therapy (infliximab, cyclosoporine,tacrolimus) or colectomy within 5 days of enrolment, as judged by the caring physician.
- Known allergy to more than one antibiotic regimen from the list below.

Malattia confinata al retto (proctite)
- Terapia antibiotica nelle precedenti 3 settimane
- MC o altre malattie infiammatorie del piccolo intestino sospette per MC;
- Infezioni dimostrate con coprocolture, ricerca di tossine C. difficile, infezioni urinarie, celluliti, ascessi, polmoniti etc
- Febbre con T>38,5°C, o con T>38 °C non correlabile all’attività del processo infiammatorio intestinale
- Necessità di ricorrere a terapia chirurgica in urgenza (megacolon tossico, emorragie massive etc)
- Probabilità che si renda necessaria una terapia medica di seconda linea entro 5 giorni dall’arruolamento
- Allergie note a più di una classe di antibiotici
- Gravidanza e/o allattamento
- Uso di anti-TNF in anamnesi.

E.5 End points

E.5.1

Primary end point(s)

Total PUCAI score at day 5 after treatment (compared between the two treatment groups).

Valutare la differenza del PUCAI (Pediatric Ulcerative Colitis Activity Index) score al quinto giorno di trattamento nel gruppo trattato con terapia antibiotica combinata a steroidi rispetto ai bambini trattati con terapia convenzionale;

E.5.1.1

Timepoint(s) of evaluation of this end point

5 days

5 giorni

E.5.2

Secondary end point(s)

1. Remission rates (defined by PUCAI<10) without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy, at days 7, separately at discharge, separately at day 14, and separately at 90 days.; 2. Number of patients with PUCAI<35 points at day 5, without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy; The need for second line therapy by discharge, by 90 days and after 1 year; Rate of steroid-dependency after 1 year of treatment; Calprotectin levels at 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; Change in microbiome pattern; Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) 14 days, 1, 2, 3, 6 and 12 months after treatment; Rate of C. difficile infection 14 days, 1, 2, 3, 6 and 12 months after treatment

Valutare i tassi di remissione (definiti con un PUCAI<10) senza la necessità di ricorrere ad una terapia di seconda linea (anti-TNF, ciclosporina o tacrolimus) o a colectomia, al giorno 7, alla dimissione, al giorno 14, e a 90 giorni; Valutare il numero di pazienti con un PUCAI<35 al giorno 5,senza la necessità di ricorrere ad una terapia di seconda linea o a colectomia; Valutare la necessità di ricorrere ad una terapia di seconda linea o a colectomia alla dimissione, a 90 giorni e ad un anno; Valutare il tasso di steroido-dipendenza ad un anno ( definito come un periodo maggiore di 3 mesi con tentativi falliti di sospendere la terapia steroidea o trattamento steroideo continuativo per 4 mesi durante l’anno); Valutare i livelli di calprotectina nei giorni 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; Valutare le modificazioni del microbioma nei giorni 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; Valutare la presenza di batteri resistenti a livello intestinale al giorno 14 e nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; Valutare il tasso di incidenza di infezioni da C. difficile al giorno 14, e nei mesi 1, 2, 3, 6, 12 dopo il trattamento con analisi PCR

E.5.2.1

Timepoint(s) of evaluation of this end point

7, 14, 90 days after treatment and at discharge; 5 days after treatment; after 90 days and 1 year after treatment and at discharge; 1 year after treatment; 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; 14 days, 1, 2, 3, 6 and 12 months after treatment; 14 days, 1, 2, 3, 6 and 12 months after treatment

7, 14, 90 giorni dopo il trattamento e dimissione; 5 giorni dopo il trattamento; dopo 90 giorni e un anno dopo il trattamento e alla dimissione; 1 anno dopo il trattamento; 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; 0, 5, 14, alle dimissioni, nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; giorno 14 e nei mesi 1, 2, 3, 6 e 12 dopo il trattamento; giorno 14, e nei mesi 1, 2, 3, 6, 12 dopo il trattamento

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

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)

Yes

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

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

Sola terapia steroidea convenzionale con Metilprednisolone (IMP6)

Steroid therapy with Methylprednisolone alone (IMP6)

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Israel

Finland

Italy

Poland

Romania

Spain

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Routine care according to the disease

Quelli previsti da normale pratica clinica

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

2015-08-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-11

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

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