Clinical Trials Register

Summary
EudraCT Number:	2021-001332-26
Sponsor's Protocol Code Number:	IJG-SCOUT-2021
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:	2021-07-02
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

2021-001332-26

A.3

Full title of the trial

Clinical effectiveness and bacteriological eradication of 3 short-course antibiotic regimens and single-dose of fosfomicyn trometamol for lower urinary tract infections in adult women [SCOUT study].

Efectividad clínica y erradicación bacteriológica de 3 pautas antibióticas cortas y monodosis de fosfomicina trometamol en las infecciones urinarias bajas no complicadas en mujeres adultas [Estudio SCOUT]

A.3.1

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

Clinical effectiveness and bacteriological eradication of 3 short-course antibiotic regimens and single-dose of fosfomicyn trometamol for lower urinary tract infections in adult women [SCOUT study]

A.3.2

Name or abbreviated title of the trial where available

SCOUT

A.4.1

Sponsor's protocol code number

IJG-SCOUT-2021

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	IDIAP Jordi Gol
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	Carlos III Institute of Research, Ministry of Economy and Competitiveness (Spain). ICI2020 Research Grant
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	IDIAP Jordi Gol
B.5.2	Functional name of contact point	Unitat Estudis Medicament
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes, 587
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08007
B.5.3.4	Country	Spain
B.5.4	Telephone number	34934824644
B.5.5	Fax number	34934824174
B.5.6	E-mail	rmonfa@idiapjgol.info

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.2.1.2	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	Nitrofurantoína
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	NITROFURANTOIN
D.3.9.1	CAS number	67-20-9
D.3.9.3	Other descriptive name	Nitrofurantoina
D.3.9.4	EV Substance Code	SUB09326MIG
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	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	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.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.2.1.2	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	Pivmecillinam
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	PIVMECILLINAM
D.3.9.1	CAS number	32886-97-8
D.3.9.3	Other descriptive name	Pivmecillinam
D.3.9.4	EV Substance Code	SUB09951MIG
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	200
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.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.2.1.2	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	Fosfomicina trometamol
D.3.4	Pharmaceutical form	Powder for oral solution in sachet
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	FOSFOMYCIN TROMETAMOL
D.3.9.1	CAS number	23155-02-4
D.3.9.3	Other descriptive name	Fosfomicina trometamol
D.3.9.4	EV Substance Code	SUB02263MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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.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.2.1.2	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	Fosfomicina trometamol
D.3.4	Pharmaceutical form	Powder for oral solution in sachet
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	FOSFOMYCIN TROMETAMOL
D.3.9.1	CAS number	23155-02-4
D.3.9.3	Other descriptive name	Fosfomicina trometamol
D.3.9.4	EV Substance Code	SUB02263MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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

Uncomplicated Lower urinary tract infections (uLUTI)

Infección Urinaria Baja No Complicada (IUBNC)

E.1.1.1

Medical condition in easily understood language

Urinary infection

Infección urinaria

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

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	10046544
E.1.2	Term	Urinary infection
E.1.2	System Organ Class	100000004862

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 main aim of the trial is double:
(1) Evaluate the clinical effectiveness of the 3 short-course antibiotic regimens (3 g of fosfomycin once daily for two-days; three-day pivmecillinam 400 mg. t.i.d.; five-day nitrofurantoin 100 mg t.i.d.) and the single 3 g dose of fosfomycin in uncomplicated LUTIs in adult women at day 7; and
(2) Assess the bacteriological eradication in the four medication arms, measured at day 14.

El objetivo principal es doble:
(1) Evaluar la efectividad clínica de 3 pautas antibióticas cortas (3 g de fosfomicina trometamol una vez al día, 2 días; pivmecillinam 200 mg. 2 comp t.i.d., 3 días; nitrofurantoína 50 mg 2 comp. t.i.d., 5 días y monodosis de fosfomicina trometamol 3 g en el día 7; y
(2) Evaluar la erradicación bacteriológica en el día 14 en cada una de las estrategias del ensayo clínico.

E.2.2

Secondary objectives of the trial

To evaluate in the four medication arms:
- Time to clinical recovery.
- Bacteriological efficacy at day 28.
- Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria.
- Proportion of patients developing complications (i.e. pyelonephritis and/or urosepsis) within the first 4 weeks.
- Treatment Adherence
- Proportion of patients who have taken another antibiotic during the study period.
- Satisfaction with care.
- Change in the quality of life.
- Mapping of uropathogens causing uncomplicated LUTIs and resistance rates to the antibiotics evaluated in the project.
- Predictive value of the different clinical criteria collected with microbiologically-confirmed LUTI.
- Cost-effectiveness of each of the treatment arms (cost of the drug, consumption of resources and indirect costs).

Evaluate the adverse reactions in each of the test strategies

Evaluar en los 4 grupos de medicación:
-Tiempo hasta curación clínica.
-Erradicación bacteriológica a día 28
-Nº de pacientes que se presentan con una recurrencia de los síntomas en las primeras 4 semanas y momento en que los síntomas de recurrencia aparecen y/o bacteriuria
-Nº pacientes que presentan complicaciones derivadas de la infección urinaria en las primeras 4 semanas; por ejemplo, pielonefritis y/o urosepsis
-Adherencia
-Nº pacientes que han tomado antibióticos distintos de la medicación de estudio durante el desarrollo del ensayo clínico
-Satisfacción de los pacientes
-Cambio de calidad de vida de los pacientes
-Mapear la epidemiología de los microorganismos productoras de IUBNC
-Valor predictivo de infección de orina confirmada microbiológicamente de los diferentes criterios clínicos recogidos en el estudio en el diagnóstico de infección urinaria confirmada microbiológicamente
-Coste-efectividad de cada grupo

Evaluar las reacciones adversas en cada grupo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Women of 18 years of age or older, with clinical features of uncomplicated community-acquired LUTI including:
(1) at least one of four key symptoms of LUTI: dysuria, urgency including nocturia, frequency, and/or suprapubic tenderness that could be attributed to an uncomplicated LUTI, and no alternative explanation (i.e. symptoms suggestive of
sexually-transmitted infection or vulvovaginitis), and
(2) a urine dipstick analysis positive for either nitrites or leukocyte esterase.

-Agree to participate in the clinical trial.

- Mujeres de 18 años o más, que acudan al médico de atención primaria con características clínicas de IUBNC adquirida en la comunidad que incluyen:
(1) al menos uno de los cuatro síntomas clave de IUBNC: disuria, urgencia (incluye nicturia), polaquiuria y/o dolor suprapúbico que pueda atribuirse a una IUBNC y sin una explicación alternativa que la explique (por ejemplo, síntomas que sugieran una infección de transmisión sexual o una vulvovaginitis), y
(2) Un análisis de tira reactiva de orina positivo para nitritos y/o esterasa leucocitaria.

- Y que acepten participar en el ensayo clínico.

E.4

Principal exclusion criteria

- Male sex.
- Clear signs of (i.e. high fever ≥ 38.5°C or flank pain/tenderness) or high suspicion of pyelonephritis.
- Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain).
- Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent UTI, severe neurological disease affecting the bladder).
- Pregnancy or lactation.
- Symptoms consistent with UTI in the preceding 4 weeks.
- Patients taking long-term antibiotic prophylaxis.
- Ongoing antibiotic therapy or use of any antibiotics in the previous 7 days.
- Hypersensitivity or allergy to penicillins, nitrofurantoin and/or fosfomycin.
- Moderate to severe chronic renal insufficiency (stage III or higher).
- Pre-existing polyneuropathy.
- History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin.
- Glucose-6-phosphate dehydrogenase deficiency.
- Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionacidanaemia).
- Oesophageal stricture.
- Current intake of allopurinol (i.e. increases the risk of allergic skin reaction to mecillinam) or probenecid (i.e. decreases the renal excretion of mecillinam) or valproate.
- Currently part of another clinical trial.
- Previous enrolment in the SCOUT study.
- Inability/unable to understand and/or take part in the clinical trial.
- Active neoplasia
- Terminal illness.
- Institutionalized patients
- Difficulty to perform the follow-up visits.

- Sexo masculino o mujeres menores de 18 años.
- Signos claros de (es decir, fiebre alta ≥ 38,5°C o dolor/sensibilidad en el costado) o sospecha elevada de pielonefritis.
- Síntomas que orientan a otro diagnóstico, como presencia de secreción vaginal.
- Cualquier condición que pueda conducir o predisponer a una infección urinaria complicada (es decir, sonda urinaria permanente, embarazo, terapia inmunosupresora, vías urinarias anormales, IUBNC recurrente, enfermedad neurológica grave que afecte la vejiga).
- Embarazo o lactancia.
- Síntomas compatibles con IUBNC en las 4 semanas anteriores.
- Pacientes que toman profilaxis antibiótica a largo plazo.
- Terapia con antibióticos en curso o uso de cualquier antibiótico en los 7 días anteriores.
- Hipersensibilidad o alergia a penicilinas, nitrofurantoína y/o fosfomicina.
- Insuficiencia renal crónica de moderada a grave (grado III o superior).
- Polineuropatía preexistente.
- Antecedentes de reacción pulmonar o hepática o neuropatía periférica después del uso previo de nitrofurantoína.
- Deficiencia de glucosa-6-fosfato deshidrogenasa.
- Porfiria o deficiencia de carnitina primaria sistémica o del tipo de aciduria orgánica (es decir, aciduria metilmalónica y propionacidanemia).
- Estenosis esofágica.
- Ingesta actual de alopurinol (ya que aumenta el riesgo de reacción cutánea alérgica al mecilinam), probenecid, metotrexato (disminuyen la excreción renal de mecilinam) o de ácido valproico.
- Que esté actualmente formando parte de otro ensayo clínico.
- Haber participado previamente en el estudio SCOUT.
- Incapacidad para comprender y/o participar en el ensayo clínico.
- Neoplasia activa.
- Enfermedad terminal.
- Pacientes institucionalizados.
- Dificultad para realizar las visitas programadas de seguimiento.

E.5 End points

E.5.1

Primary end point(s)

Two co-primary endpoints are considered:
· Co-primary endpoint no. 1, clinical effectiveness: proportion of patients who report being cured by day 7, defined as the resolution of the symptoms, answered by the patient.
· Co-primary endpoint no. 2, bacteriological eradication: proportion of patients bacteriologically cured at first control urine sample, day 14.

Variable principal doble:
- Variable principal 1: efectividad clínica, proporción de pacientes que afirman estar curados en el día 7.
- Variable principal 2: erradicación bacteriológica: proporción de pacientes curados bacteriológicamente en la muestra de orina del día 14.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 7 (primary end point 1)
Day 14 (primary end point 2)

Día 7 (variable principal 1)
Día 14 (variable principal 2)

E.5.2

Secondary end point(s)

- Time to clinical recovery (D0-D7).
- Bacteriological efficacy at day 28.
- Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria.
- Proportion of patients developing complications (i.e. pyelonephritis and/or urosepsis) within the first 4 weeks.
- Treatment Adherence
- Proportion of patients who have taken another antibiotic during the study period.
- Satisfaction with care.
- Change in the quality of life.
- Cost-effectiveness of each of the treatment arms
-Number of adverse reactions in each of the test strategies

-Tiempo hasta curación clínica (D0-D7).
-Erradicación bacteriológica a día 28
-Nº de pacientes que se presentan con una recurrencia de los síntomas en las primeras 4 semanas y momento en que los síntomas de recurrencia aparecen y/o bacteriuria
-Nº pacientes que presentan complicaciones derivadas de la infección urinaria en las primeras 4 semanas; por ejemplo, pielonefritis y/o urosepsis
-Adherencia al tratamiento
-Nº pacientes que han tomado antibióticos distintos de la medicación de estudio durante el desarrollo del ensayo clínico
-Satisfacción pacientes
-Cambio de calidad de vida
-Coste-efectividad
-Número reacciones adversas en cada grupo

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 7, 14 and 28

Dia 7, 14 and 28

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

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

Clinical effectiveness

Efectividad clinica

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

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)

Yes

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

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:

800

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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