Clinical Trials Register

Summary
EudraCT Number:	2016-002052-24
Sponsor's Protocol Code Number:	MERCY
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
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

2016-002052-24

A.3

Full title of the trial

Continuous infusion versus intermittent administration of meropenem in critically ill patients. A multicenter randomized double blind trial.

A.3.1

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

Continuous infusion versus intermittent administration of meropenem in critically ill patients. A multicenter randomized double blind trial.

Meropenem in infusione continua o a boli nel paziente ricoverato in terapia intensiva. Uno studio multicentrico randomizzato in doppio cieco.

A.3.2

Name or abbreviated title of the trial where available

Bolus versus continuous infusion of meropenem.

infusione continua versus infusione a boli di meropenem

A.4.1

Sponsor's protocol code number

MERCY

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	OSPEDALE SAN RAFFAELE
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	AIFA - Italian Medicines Agency
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	OSPEDALE SAN RAFFAELE
B.5.2	Functional name of contact point	ANESTESIA E RINAIMAZIONE
B.5.3	Address:
B.5.3.1	Street Address	VIA OLGETTINA 60
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390226436155
B.5.5	Fax number	+390226436152
B.5.6	E-mail	landoni.giovanni@hsr.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	Merepenem Aurobindo e Merrem di Pfizer (ex Astrazeneca)
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	MEROPENEM
D.3.2	Product code	[MEROPENEM]
D.3.4	Pharmaceutical form	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	MEROPENEM
D.3.9.1	CAS number	119478-56-7
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	4
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

We are planning a large multicentre randomized controlled study to confirm the beneficial effect of continuous infusion of meropenem against bolus administration as indicated by a composite outcome of reducing death, and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients.

Pazienti adulti affetti da sepsi e/o shock settico

E.1.1.1

Medical condition in easily understood language

Continuous infusion versus intermittent administration of meropenem in critically ill patients

Meropenem in infusione continua o a boli nel paziente ricoverato in terapia intensiva.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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	10062357
E.1.2	Term	SIRS
E.1.2	System Organ Class	100000004867

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

reducing death and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients

riduzione della comparsa di patogeni multiresistenti in pazienti ricoverati in terapia intensiva, riduzione della mortalità

E.2.2

Secondary objectives of the trial

reducing long-term mortality, days under mechanical ventilation, intensive care unit length of stay, fastening reduction of severity of disease.

riduzione della mortalità a lungo termine, dei giorni di ventilazione meccanica, dei giorni di degenza in terapia intensiva e un più rapido miglioramento delle condizioni cliniche.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Are at least 18 years old
2. Need a new antibiotic treatment, by clinical judgment, with meropenem
3. Are admitted to ICU
4. Have Sepsis or septic shock
5. Are able to express informed consent or by him/her next of kin or as requested by Ethical Committee.

1. Età superiore ai 18 anni
2. Ricovero in Terapia Intensiva
3. Necessità di meropenem secondo giudizio clinico
4. Affetti da sepsi o shock settico
5. Consenso informato firmato

E.4

Principal exclusion criteria

.1. Are able to express informed consent and denying it
2. Are already receiving study drug or other carbapenem both as a bolus or continuous infusion
3. Have a known allergy or intolerance to study drug
4. Have a little chance of survival, as defined by a SAPS II score more than 65 point
5. Have concomitant acquired immunodeficiency syndrome (stage 3 according to CDC)
6. Have received immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day for over 30 days)

1. Capace di esprimere un consenso informato e rifiuto di questo
2. Già in corso la somministrazione, in ogni modo, di qualunque carbapenemico
3. Nota allergia o intolleranza al farmaco in studio
4. Scarse probabilità di sopravvivere, definite da un punteggio SAPS II > 65
5. Concomitante AIDS (oltre stadio 3 secondo CDC)
6. Concomitante terapia immunosoppressiva o corticosteroidea di lunga data (oltre 0.5 mg/kg/die di idrocortisone per oltre 30 giorni)

E.5 End points

E.5.1

Primary end point(s)

reducing death and emergence of extensive or pan drug resistant pathogens in a population of severely ill patients

riduzione della comparsa di patogeni multiresistenti in pazienti ricoverati in terapia intensiva, riduzione della mortalità

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 giorni

E.5.2

Secondary end point(s)

reducing long-term mortality, days under mechanical ventilation, intensive care unit length of stay, fastening reduction of severity of disease.

riduzione della mortalità a lungo termine, dei giorni di ventilazione meccanica, dei giorni di degenza in terapia intensiva e un più rapido miglioramento delle condizioni cliniche.

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

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

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)

Yes

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

Information not present in EudraCT

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

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

Since with a high probability, the study population will be composed of unconscious patients and therefore, unable to give their informed consent in emergency cases everytime when the legal representative will be absent, the investigator will decide

Poiché con buona probabilità, la popolazione in studio sarà composta da pazienti incoscienti e pertanto incapaci di rilasciare il proprio consenso, in situazioni di emergenza, qualora non sia disponibile un rappresentante legale, lo sperimentatore po

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

600

F.4.2

For a multinational trial

F.4.2.1

In the EEA

600

F.4.2.2

In the whole clinical trial

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)

nothing

nessuna

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

2017-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-11-03

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