Clinical Trials Register

Summary
EudraCT Number:	2013-001663-23
Sponsor's Protocol Code Number:	CAP01-2013
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:	2013-06-27
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

2013-001663-23

A.3

Full title of the trial

Clinical and immunomodulatory effects of antibiotic therapy + pidotimod versus antibiotic therapy alone in patients with community-acquired pneumonia (CAP)

Effetti immunomodulatori e clinici della terapia antibiotica + pidotimod versus la sola terapia antibiotica in pazienti affetti da polmonite acquisita in comunità (CAP)

A.3.1

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

Effect on the clinical development and on the immune system of the use of Pidotimod in addition to the antibiotic in the treatment of pneumonia.

Effetto sull’evoluzione clinica e sul sistema immunitario dell’uso di Pidotimod in aggiunta all’antibiotico nel trattamento della polmonite.

A.4.1

Sponsor's protocol code number

CAP01-2013

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	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
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	VALEAS S.P.A. IND.CHIM.FARMACEUTICA
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	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
B.5.2	Functional name of contact point	U.O. BRONCOPNEUMOLOGIA
B.5.3	Address:
B.5.3.1	Street Address	VIA F. SFORZA N. 35
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39250320623
B.5.5	Fax number	+39250320625
B.5.6	E-mail	francesco.blasi@unimi.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	AXIL 800mg granulato per soluzione orale
D.2.1.1.2	Name of the Marketing Authorisation holder	Polichem 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.3.4	Pharmaceutical form	Granules 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	PIDOTIMOD
D.3.9.1	CAS number	121808-62-6
D.3.9.4	EV Substance Code	SUB09826MIG
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	800
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	Granules for oral solution
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Community acquired pneumonia

Polmoniti acquisite in comunità

E.1.1.1

Medical condition in easily understood language

Pneumonia not acquired during hospitalization

Polmoniti acquisite in soggetti non ricoverati

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	16.0
E.1.2	Level	PT
E.1.2	Classification code	10060946
E.1.2	Term	Pneumonia bacterial
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

To evaluate the clinical effects of treatment with pidotimod in addition to antibiotic therapy in patients with Community acquired pneumonia on inflammatory markers (C-reactive protein: CRP).

Valutare gli effetti clinici del trattamento con pidotimod in aggiunta alla terapia antibiotica in pazienti affetti da polmonite acquisita in comunità sui marker infiammatori (Proteina C-Reattiva: PCR).

E.2.2

Secondary objectives of the trial

Evaluate the efficacy of antibiotic + pidotimod in improving the patient's response to therapy by increasing the immune system through the dosing of some specific markers

Valutare l’efficacia dell’associazione antibiotico+pidotimod nel migliorare la risposta del paziente alla terapia aumentando le difese immunitarie attraverso il dosaggio di alcuni specifici marker

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.of both sexes
2. aged between 30 and 64 years (age ≥ 30 years and ≤ 64 years)
3. diagnosis of pneumonia. New pulmonary infiltrate diagnosed with radiography (Rx) or computed tomography (CT) of the chest within 48 hours of admission, in addition to at least two of the following parameters:
a) develop a cough or increase of the same if already present, with or without sputum production and / or purulent respiratory secretions;
b) fever (rectal or oral temperature ≥ 37.8 ° C documented) or hypothermia (rectal or oral temperature documented <36 ° C);
c) evidence of a systemic inflammation: increase in C-reactive protein (CRP) above the limit value of the center;
4. from community and hospitalized in the previous 14 days;
5. severity of pneumonia of mild to moderate: PSI: III and IV oCURB-65: 0-2

1. di ambo i sessi
2. di età compresa tra i 30 e i 64 anni (età ≥30 anni e ≤64 anni)
3. diagnosi di polmonite. Nuovo infiltrato polmonare diagnosticato con radiografia (Rx) o tomografia computerizzata (TC) del torace entro le 48 ore dal ricovero, in aggiunta ad almeno due tra i seguenti parametri:
a) comparsa di tosse o aumento della stessa se già presente,
con o senza produzione di espettorato e/o secrezioni respiratorie purulente;
b) febbre (temperatura corporea≥ 37,5 °C)o ipotermia (temperatura rettale o orale documentata <36°C);
c) evidenza di una infiammazione sistemica: aumento della proteina C-reattiva (PCR) al di sopra del valore limite del centro;
4. provenienti dalla comunità e non ricoverati nei precedenti 14 giorni;
5. severità della polmonite di grado lieve o moderato:PSI: III e IV oCURB-65: 0-2

E.4

Principal exclusion criteria

patients with immunodeficiency due to:
a) chemotherapy in the 12 months prior to entry into the hospital;
b) radiation in the 12 months prior to entry into the hospital;
c) organ transplant;
d) immunosuppressive treatment;
e) active haematological neoplasm;
f) AIDS or HIV with CD4 counts <200;
g) asplenia.
2. patients with community-acquired pneumonia framed with community Health-care acquired pneumonia (HCAP), that occurs in a patient with one or more of the following risk factors:
a) hospitalization for 2 days or more in the last 90 days;
b) from nursing home or residential care;
c) who has received an infusion therapy, including those with antibiotics, at home or who showed sores in the previous 30 days;
d) that has been on dialysis in the last 30 days;
3. patients with other concomitant infection (eg urinary tract infection) at the time of hospitalization that requires antibiotic therapy. The presence of sepsis in the course of pneumonia will not be considered as another co-infection;
4. patients with documented bacteremia with S. aureus (both methicillin sensitive and methicillin resistant);
5. with pneumonia due to fungi, mycobacteria, or Pneumocystis jirovecii;
6. Patients with an allergy or intolerance to fluoroquinolones and pidotimod;
7. Patients treated with systemic corticosteroids;
women who are pregnant or breast-feeding, and if of childbearing age, are not protected by adequate contraception.

1. pazienti con immunodeficienza conseguente a:
a) chemioterapia nei 12 mesi precedenti l’ingresso in ospedale;
b) radioterapia nei 12 mesi precedenti l’ingresso in ospedale;
c) trapianto d’organo;
d) trattamento immunosoppressivo;
e) neoplasia ematologica attiva;
f) AIDS o HIV con conta dei CD4 <200;
g) asplenia.
2. pazienti con polmonite acquisita in comunità inquadrabile con Health-care community acquired pneumonia (HCAP), cioè che si verifichi in un soggetto con uno o più dei seguenti fattori di rischio:
a) ricovero in ospedale per 2 giorni o più negli ultimi 90 giorni;
b) proveniente da casa di cura o struttura assistenziale;
c) che ha ricevuto una terapia infusionale, compresa quella a base di antibiotici, al domicilio o che ha mostrato piaghe da decubito nei 30 giorni precedenti;
d) che è stato in dialisi negli ultimi 30 giorni;
3. pazienti con altra infezione concomitante (es: infezione delle vie urinarie) al momento del ricovero in ospedale che richieda terapia antibiotica. La presenza di sepsi in corso di polmonite non verrà considerata un’altra concomitante infezione;
a) pazienti con documentata batteriemia da S. aureus (sia meticillino sensibile che meticillino resistente);
b) con polmonite dovuta a funghi, micobatteri o Pneumocystis jirovecii;
c) pazienti con allergia o intolleranza ai fluorochinoloni e a pidotimod;
d) pazienti in trattamento con cortisonici sistemici;
donne in gravidanza o in allattamento e, se in età fertile, non protette da adeguata contraccezione.

E.5 End points

E.5.1

Primary end point(s)

Time (days) for achieve the absence of CRP increase in comparison with the day before

Tempo (giorni) di raggiungimento dell’assenza di incremento della PCR rispetto al giorno precedente.

E.5.1.1

Timepoint(s) of evaluation of this end point

The maximum time for the achieve the end point is 5 days

Il tempo Massimo per raggiungere l’endpoint è 5 giorni.

E.5.2

Secondary end point(s)

• Time (days) to achieve the CRP value in the normal range.
• Time (days) to achieve clinical stability.
• Final clinical judgment

• Tempo (giorni) per raggiungere il range normale di PCR.
• Tempo (giorni) per raggiungere la stabilità clinica
• Giudizio clinico finale

E.5.2.1

Timepoint(s) of evaluation of this end point

Time / rate measurement of this endpoint:
Days 2-3-4-5 and the day after the antibiotic treatment provided at the discretion of the investigator, at 7 or 10 days of treatment

Tempo/i di rilevazione di questo end point:
ai giorni 2-3-4-5 e al termine del trattamento antibiotico previsto, a discrezione dello Sperimentatore, al 7 o al 10 giorno di 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)

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

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

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.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)

Not pertinent

Non pertinente

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

2013-09-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-11

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

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