Clinical Trials Register

Summary
EudraCT Number:	2011-002603-15
Sponsor's Protocol Code Number:	GANCMV-2011
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-09-28
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

Spain - AEMPS

A.2

EudraCT number

2011-002603-15

A.3

Full title of the trial

Early treatment with ganciclovir of active infection by cytomegalovirus (CMV) in critically ill patients on mechanical ventilation with severe sepsis or septic shock

Tratamiento anticipado con ganciclovir de la infección activa por el citomegalovirus (CMV) en el paciente crítico en ventilación mecánica con sepsis grave o shock séptico

A.3.1

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

Study for the treatment of cytomegalovirus infection in critically ill patients on mechanical ventilation

Estudio del tratamiento de la infeccion por citomegalovirus en pacientes criticos con ventilacion mecanica.

A.4.1

Sponsor's protocol code number

GANCMV-2011

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	FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
B.1.3.4	Country	Spain
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	Ministerio de Sanidad y Politica Social
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
B.5.2	Functional name of contact point	UNIDAD ENSAYOS CLINICOS
B.5.3	Address:
B.5.3.1	Street Address	AVENIDA BLASCO IBAÑEZ, 17
B.5.3.2	Town/ city	VALENCIA
B.5.3.3	Post code	46010
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034963862894
B.5.5	Fax number	0034963987860
B.5.6	E-mail	fundacioninvestigacion_hcv@gva.es

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	CYMEVENE
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE FARMA, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	CYMEVENE
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	GANCICLOVIR SODIUM
D.3.9.1	CAS number	107910-75-8
D.3.9.3	Other descriptive name	GANCICLOVIR SODIUM
D.3.9.4	EV Substance Code	SUB02312MIG
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	54.6
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	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

Active infection with cytomegalovirus (CMV) in critically ill patients on mechanical ventilation with severe sepsis or septic shock

Infección activa por el citomegalovirus (CMV) en el paciente crítico en ventilación mecánica con sepsis grave o shock séptico

E.1.1.1

Medical condition in easily understood language

Cytomegalovirus infection in critically ill patients on mechanical ventilation

Infeccion por citomegalovirus en paciente critico en ventilacion mecanica

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10011831
E.1.2	Term	Cytomegalovirus infection
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

Determine the efficacy of early administration of ganciclovir against CMV infection, guided by the virological monitoring (presence of viral DNA in respiratory secretions and plasma) in patients with severe sepsis or septic shock admitted to the ICU. Efficacy was assessed by the percentage of patients with negative conversion of CMV in blood and tracheal aspirate at the end of treatment (14 days).

Determinar la eficacia de la administración anticipada de ganciclovir frente a la infección por CMV, guiado por la monitorización virológica (presencia de DNA viral en secreción respiratoria y plasma) en pacientes con sepsis severa o shock séptico ingresados en la UCI. La eficacia se evaluará por el porcentaje de pacientes con negativización del CMV en sangre y aspirado traqueal al finalizar el tratamiento (14 días).

E.2.2

Secondary objectives of the trial

-Assess the safety of administration of ganciclovir in these patients in terms of neutropenia (neutrophils <1.0 x 10^9 / L and <0.5 x 10^9 / L).

-Evaluate the outcome of patients treated with ganciclovir compared with placebo in terms of days of mechanical ventilation, length of ICU stay, frequency and type of concomitant infections.

-Evaluar la seguridad de la administración de ganciclovir en estos pacientes en términos de aparición de neutropenia (Neutrófilos <1.0 x 10^9/L y < 0,5 x 10^9/L).

-Evaluar el resultado final de los pacientes tratados con ganciclovir frente a los tratados con placebo en términos de días de ventilación mecánica invasiva, tiempo de estancia en UCI y frecuencia y tipo de infecciones concomitantes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Signing the informed consent (patient or family)
? Age equal or greater than 18 years
? Positive serology for CMV (IgG and/or IgM) at the time of admission
? active CMV infection during their ICU stay (> 10 CMV DNA copies/ml of tracheal aspirate and/or peripheral blood).
? Severe sepsis or septic shock (it will follow the definitions of the consensus conference) requiring mechanical ventilation.
? Women of childbearing potential must test negative serum or urine test and use effective contraception.
? Admitted to ICU

?Firma del Consentimiento Informado (paciente o familiares)
?Edad igual o mayor a 18 años
?Serología positiva para el CMV (IgG y/o IgM) en el momento del ingreso
?Infección activa por CMV durante su estancia en la UCI (>10 copias DNA CMV/ml de aspirado traqueal y/o sangre periférica).
?Sepsis severa o shock séptico (se seguirán las definiciones de la conferencia de consenso) que precisen ventilación mecánica.
?Las mujeres en edad fértil deben tener resultado negativo en test de orina o suero y utilizar métodos anticonceptivos eficaces.
?Ingresados en UCI

E.4

Principal exclusion criteria

? Patients who are participating in other clinical trials.
? Immunosuppression known at the time of admission
? Neutropenia (neutrophils <500/?l)
? Thrombocytopenia (<25x10^9/L)
? Liver failure: bilirubin>2 mg/dL
? Patients who are pregnant or breastfeeding.
? Other contraindications listed in the Summary of ganciclovir

?Pacientes que estén participando en otros Ensayos Clínicos.
?Inmunosupresión conocida en el momento del ingreso
?Neutropenia (neutrofilos <500/µl)
?Trombocitopenia (<25x10^9/L)
?Fallo hepático: Bilirrubina > 2 mg/dL
?Pacientes embarazadas o en periodo de lactancia.
?Otras contraindicaciones contempladas en la ficha técnica del ganciclovir.

E.5 End points

E.5.1

Primary end point(s)

Determine the percentage of patients with negative conversion of CMV in blood and tracheal aspirate at the end of treatment (14 days). That figure is compared with that obtained with placebo.

Determinar el porcentaje de pacientes con negativización del CMV en sangre y aspirado traqueal al finalizar el tratamiento (14 días). Esa cifra se comparará con la obtenida con un grupo placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 times per week from the diagnosis of active CMV infection until discharge from ICU.

Periodicidad de 2 veces por semana, desde el diagnóstico de infección activa por CMV hasta su alta de UCI.

E.5.2

Secondary end point(s)

? Assess the safety of the administration of ganciclovir in these patients in terms of neutropenia (neutrophils <1.0 x 10^9 / L and <0.5 x 10^9 / L). To determine this, researchers use in blood tests periodically (every 24 hours) are performed routinely in these patients

? Evaluate the outcome of patients treated with ganciclovir compared with placebo in terms of days of mechanical ventilation, ICU length of stay and type and frequency of concomitant infections (pulmonary, bacteremia, surgical wound infection, urinary)

?Evaluar la seguridad de la administración de ganciclovir en estos pacientes en términos de aparición de neutropenia (Neutrófilos <1.0 x 10^9/L y < 0,5 x 10^9/L). Para determinarlo los investigadores se basarán en las analíticas de sangre que periódicamente (cada 24 horas) se realizan de rutina en este tipo de pacientes.

?Evaluar el resultado final de los pacientes tratados con ganciclovir frente a los tratados con placebo en términos de días de ventilación mecánica, tiempo de estancia en UCI y frecuencia y tipo de infecciones concomitantes (pulmonar, bacteriemia, infección de la herida quirúrgica, urinarias)

E.5.2.1

Timepoint(s) of evaluation of this end point

-Every 24 hours

-At the end of treatment

-Cada 24 horas

-Al final del tratamiento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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)

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

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:

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

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

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)

REGULAR MONITORING IN PATIENTS

SEGUIMIENTO HABITUAL EN PACIENTES

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

2011-11-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-29

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

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