Clinical Trials Register

Summary
EudraCT Number:	2011-001521-25
Sponsor's Protocol Code Number:	2
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-19
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2011-001521-25

A.3

Full title of the trial

: NEOMERO 2: FARMACOCINÉTICA Y SEGURIDAD DE MEROPENEM EN NIÑOS DE EDADES HASTA 90 DÍAS (INCLUSIVE) CON MENINGITIS PROBABLE O CONFIRMADA: ENSAYO MULTICÉNTRICO EUROPEO DE FASE I-II

A.3.1

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

: NEOMERO 2: FARMACOCINÉTICA Y SEGURIDAD DE MEROPENEM EN NIÑOS DE EDADES HASTA 90 DÍAS (INCLUSIVE) CON MENINGITIS

A.3.2

Name or abbreviated title of the trial where available

NEOMERO 2

A.4.1

Sponsor's protocol code number

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/001/2010

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	PENTA Foundation Onlus
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	European Commission
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PENTA Foundation Onlus
B.5.2	Functional name of contact point	Silvia Faggion
B.5.3	Address:
B.5.3.1	Street Address	Via Giustiniani, 3
B.5.3.2	Town/ city	Padova
B.5.3.3	Post code	35128
B.5.3.4	Country	Italy
B.5.4	Telephone number	+393470957171
B.5.5	Fax number	+390498753865
B.5.6	E-mail	management@neomero.org

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	MEROPENEM
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	MEROPENEM
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intravenous drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEROPENEM TRIHYDRATE
D.3.9.1	CAS number	119478-56-7
D.3.9.2	Current sponsor code	MERONEM
D.3.9.3	Other descriptive name	MEROPENEM TRIHYDRATE
D.3.9.4	EV Substance Code	SUB21617
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 10
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Meningitis en niños menores de 90 días

E.1.1.1

Medical condition in easily understood language

Meningitis en niños menores de 90 días

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Estudiar la farmacocinética(en plasma y líquido cefalorraquídeo) de meropenem en niños de hasta 90 días (inlcusive) de edad postnatal con meningitis bacteriana probable o confirmada; igualmente, caracterizar el perfil de seguridad de meropenem en el tratamiento de niños de hasta 90 días (inclusive) de edad postnatal con meningitis bacteriana probable o confirmada

E.2.2

Secondary objectives of the trial

Describir la eficacia de meropenem, evaluar la supervivencia, evaluar recaídas o nuevas infecciones, definir los organismos que causan la meningitis neonatal, describir la sensibilidad antibacteriana de los organismos que causan meningitis y describir la respuesta clínica y microbiológica según esto, evaluar la colonización de la mucosa por organismos resistentes antes y después del tratamiento con meropenem, evaluar la erradicación bacteriana y evaluar los parámetros genéticos funcionales que pueden afectar a la respuesta al tratamiento.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Farmacocinética de meropenem en neonatos menores de 90 días de edad postnatal con menintis. 08-07-2011. Version 21.0
Subestudio microbiológico. 08-07-2011. Versión 2.0
Determinantes genéticos de susceptibilidad a meningitis y a respuesta diferencial a meropenem. 08-07-2011. Version 2.0

E.3

Principal inclusion criteria

Consentimiento informado firmado por los padres, edad menor a 90 días, presencia de signos clínicos compatibles con meningitis bacteriana o pleocitosis en líquido cefalorraquídeo o tinción de gram positiva en líquido cefalorraquídeo

E.4

Principal exclusion criteria

Presencia de un dispositivo de extracción de líquido cefalorraquídeo, diagnóstico de meningitis vírica o fúngica, malformaciones congénitas graves con expectativa de vida menor de 3 meses, situaciones en las que el médico a cargo considere que es necesario un régimen de tratamiento empírico con antibiótico diferente, certeza de intolerancia o contraindicación de la medicación de estudio, participación en cualquier otro estudio con medicación en investigación, fallo renal que requiera hemofiltración o diálisis peritoneal, meningitis por organismos del que se conozca su resistencia a meropenem.

E.5 End points

E.5.1

Primary end point(s)

? La FC de meropenem (en plasma y LCR) niños de hasta 90 días (inclusive) de edad con diagnóstico de MB probable y confirmado
? Eventos adversos experimentados por niños tratados con meropenem. Se registrarán todos los Eventos adversos clínicos y biológicos observados hasta la visita de seguimiento (FU).

E.5.1.1

Timepoint(s) of evaluation of this end point

Hasta los 45 días +/- 3, fecha de seguimiento

E.5.2

Secondary end point(s)

? Se define como resultado favorable en la visita de la Prueba de Curación (TOC), 2 días después de la FDTA, como el cumplimiento por el paciente de los siguientes criterios: supervivencia con resolución clínica y bacteriológica (ver Anexo A) de las alteraciones que definen a la MB en el inicio, y ausencia de ninguna nueva alteración clínica ni de laboratorio que requiera nuevo tratamiento con antibióticos ni la modificación del tratamiento inicial con meropenem (durante más de 24 horas).
? Respuesta clínica, biológica y microbiológica en el día 3, en el FDTA, en la visita TOC y en la de seguimiento (FU);
? Supervivencia en la visita FU;
? Se evalúa la función auditiva mediante los potenciales auditivos evocados del tronco cerebral entre las visitas de COT y FU;
? Se evalúa la función neurológica por ecografías cerebrales (y, en caso de presentar alteraciones, por RM o TC) en cualquier momento hasta la visita de FU;
? Los organismos que causan meningitis neonatal;
? La sensibilidad al antibiótico de las bacterias que causan MB;
? Colonización de mucosa con bacterias u hongos resistentes al antibiótico en el momento del reclutamiento del sujeto, en la FDTA y en FU I alta (lo que ocurra antes)
? Parámetros genéticos que pueden afectar a la respuesta al tratamiento

E.5.2.1

Timepoint(s) of evaluation of this end point

Hasta 45+/- 3 días, fecha de seguimiento

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Meropenem pharmacokinetics in plasma and cerebrospinal fluid

Farmacocinética en plasma y líquido cefalorraquídeo de meropenem

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

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

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

Última visita del último paciente incluido en el estudio

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

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Neonatos y niños menores de 90 días

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)

Ninguno

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

2012-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-17

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials