Clinical Trials Register

Summary
EudraCT Number:	2015-000203-89
Sponsor's Protocol Code Number:	NeoVanc
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-12-09
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

2015-000203-89

A.3

Full title of the trial

Multi-centre, randomised, open label, phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged less than or equal to 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms

Estudio multicéntrico, aleatorizado y abierto en fase IIb para comparar la eficacia, seguridad y farmacocinética (PK) de la dosis óptima y la dosis estándar de vancomicina en neonatos y niños menores o iguales a 90 días de vida con sospecha de sepsis o sepsis confirmada por gérmenes gram-positivos.

A.3.1

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

Multi-centre, European study to compare how well the standard course of the antibiotic vancomycin works compared to a new vancomycin course in babies aged less than 91 days with sepsis occurring after 3 days of life

Estudio Europeo para comparar el tratamiento convencional con vancomicina con una nueva pauta de vancomicina en niños de menos de 91 días de vida con sepsis que comience después del tercer día de vida.

A.3.2

Name or abbreviated title of the trial where available

Neonatal Vancomycin Trial (NeoVanc)

Ensayo clínico neonatal con Vancomicina (NeoVanc)

A.4.1

Sponsor's protocol code number

NeoVanc

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02790996

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/026/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fondazione PENTA 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	EU FP7 (Seventh Framework Programme - FP7-HEALTH-2013-INNOVATION-1, Grant Agreement 602041)
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	St George’s, University of London
B.5.2	Functional name of contact point	Dr Louise Hill
B.5.3	Address:
B.5.3.1	Street Address	Cranmer Terrace
B.5.3.2	Town/ city	London
B.5.3.3	Post code	SW17 0RE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00442087254851
B.5.5	Fax number	00442087250716
B.5.6	E-mail	lhill@sgul.ac.uk

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	Vancomycin 500mg Powder for Solution for Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorio Reig Jofré S.A.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Vancomycin 500mg Powder for Solution for Infusion
D.3.4	Pharmaceutical form	Powder for 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	vancomycin hydrochloride
D.3.9.1	CAS number	1404-93-9
D.3.9.3	Other descriptive name	VANCOMYCIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB05077MIG
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	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Comparator
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	Vancomycin 500mg Powder for Solution for Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorio Reig Jofré S.A.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Vancomycin 500mg Powder for Solution for Infusion
D.3.4	Pharmaceutical form	Powder for 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	vancomycin hydrochloride
D.3.9.1	CAS number	1404-93-9
D.3.9.3	Other descriptive name	VANCOMYCIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB05077MIG
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	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

Neonatal late onset sepsis

Sepsis neonatal de aparición tardía

E.1.1.1

Medical condition in easily understood language

Infection of the blood in babies who are more than 3 days old but less than 91 days old

Infección de la sangre en bebés con más de 3 días pero menores de 91 días de edad.

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	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10053598
E.1.2	Term	Late onset neonatal sepsis
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

To compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms

Comparar la eficacia de una dosis óptima de vancomicina frente al régimen de dosificación estándar en pacientes con diagnóstico confirmado o con sospecha de sepsis tardía por microorganismos Gram-positivos.

E.2.2

Secondary objectives of the trial

To compare the safety of vancomycin (including renal and hearing safety) by allocation group in the intention to treat (ITT) population. To describe the PK parameters according to vancomycin dosing regimen and outcome using population PK modelling in the ITT population. To describe PK/PD in terms of the probability of target attainment (PTA)
with different vancomycin dosing regimens in the ITT and per protocol (PP) populations. To describe outcomes and duration of therapy at the end of actual vancomycin therapy and at the short term follow-up visit by allocation group in the ITT and PP populations. To compare the clinical outcome to the antibacterial susceptibility of infecting organisms. To compare colonisation by resistant microorganisms [e.g. vancomycin-resistant enterococci (VRE)] and Candida spp. by allocation group at baseline, TOC and short-term follow-up.

Comparar la seguridad de Vancomicina (incluyendo seguridad renal y auditiva) en el grupo de población por intención de tratar (ITT). Describir los parámetros farmacocinéticos (PK) de acuerdo al régimen de dosificación estándar de vancomicina y resultados usando modelos poblacionales de PK en la población por ITT. Describir la PK y la farmacodinámica (PK/PD) en términos de probabilidad de cumplimiento de objetivos (PTA) con distintos regímenes de dosificación de Vancomicina en las poblaciones ITT y PP. Describir los resultados y duración de la terapia al final del tratamiento con Vancomicina y el seguimiento a corto plazo en los grupos por ITT y PP. Comparar los resultados clínicos de susceptibilidad antibacteriana a los organismos infecciosos. Comparar la colonización por microorganismos resistentes (p.e. enterococo resistente a vancomicina (VRE)) y Cándida spp. en los grupos, al inicio del estudio, test de curación (TOC) y en el seguimiento a corto plazo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Postnatal age less or equal to 90 days at randomisation
AND
Postnatal age equal to or above 72 hours at onset of sepsis
AND
Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below, in the 24 hours before randomisation
OR
Confirmed, significant bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation

Clinical criteria:
- Hyperthermia or hypothermia
- Hypotension or impaired peripheral perfusion or mottled skin
- Apnoea or increased oxygen requirement or increased requirement for ventilatory support
- Bradycardic episodes or tachycardia
- Worsening feeding intolerance or abdominal distension
- Lethargy or hypotonia or irritability

Laboratory criteria:
- White blood cell (WBC) count < 4 or > 20 x 10^9 cells/L
- Immature to total neutrophil ratio (I/T) > 0.2
- Platelet count < 100 x 10^9/L
- C-reactive protein (CRP) > 10 mg/L
- Glucose intolerance as defined by a blood glucose value > 180 mg/dL (> 10 mmol/L) when receiving normal glucose amounts (8 – 15 g/kg/day)
- Metabolic acidosis as defined by a base excess (BE) < –10 mmol/L (< –10 mEq/L) or a blood lactate value > 2 mmol/L

Edad postnatal ≤ 90 días en el momento de la aleatorización
Y
Edad postnatal ≥ 72 horas al inicio de la sepsis.
Y
Sepsis clínica definida como la presencia de cualquiera de estos 3 criterios clínicos o analíticos detallados a continuación, en las 24 horas previas a la aleatorización
O
Sepsis confirmada definida como la presencia de hemocultivo positivo para gérmenes Gram-positivos en una muestra normalmente estéril y al menos un criterio clínico o analítico de los detallados a continuación en las 24 horas previas a la aleatorización

Criterios clínicos:
•Hipertermia o hipotermia.
•Hipotensión o alteración de la perfusión periférica o cutis marmorata
•Apnea o aumento de requerimientos de oxígeno o del soporte ventilatorio
•Episodios de bradicardia o taquicardia
•Intolerancia digestiva o distensión abdominal
•Letargia, hipotonía o irritabilidad

Criterios de Laboratorio:
•Recuento serie blanca (WBC) < 4 o > 20 x 109 cel/L
•Ratio neutrófilos inmaduros- neutrófilos totales(I/T) > 0.2
•Recuento de plaquetas < 100 x 109/L
•Proteína C reactiva (PCR) > 10 mg/L
•Intolerancia a la glucosa definida como valores de glucosa en sangre > 180 mg/dL (> 10 mmol/L) con aportes normales de glucosa (8 – 15 g/kg/día)
Acidosis metabólica definida con exceso de bases (BE) < –10 mmol/L (–10 mEq/L) o valores de lactato en sangre > 2 mmol/L

E.4

Principal exclusion criteria

- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- Treatment with vancomycin for ≥ 24 hours at any time within 7 days of randomisation
- Known toxicity, hypersensitivity or intolerance to vancomycin
- Known acute renal impairment as defined by urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value ≥ 100 μmol/L (1.13 mg/dL)
- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
- Severe congenital malformations where the infant is not expected to survive for more than 3 months
- Patient known to have S. aureus (MSSA or MRSA) bacteraemia
- Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
- Patient with high suspicion of/confirmed sepsis caused by Gramnegative organisms or fungi
- Other situations where the treating physician considers a different empiric antibiotic regimen necessary
- Current participation in any other clinical study of an investigational medicinal product (IMP)

Post-randomisation exclusions from analysis of efficacy
- Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, urinary tract infection, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety. If these exclusions exceed 10% of participants recruited then there is the option to replace the excluded babies in order to maintain the integrity of the trial

•Administración de cualquier régimen de tratamiento antibiótico durante más de 24 horas, previas a la aleatorización a menos que el cambio sea derivado por la falta de eficacia del tratamiento original
• Tratamiento con Vancomicina ≥ 24 horas en los primeros 7 días de desde el reclutamiento
• Toxicidad, hipersensibilidad o intolerancia conocida a la Vancomicina
• Afectación renal conocida, definida como diuresis < 0.7 ml/kg/hora durante 24 horas o cifra de creatinina ≥ 100 µmol/L (1.13 mg/dL)
• Tratamiento (o plan de tratamiento) con hemofiltración, hemodiálisis, diálisis peritoneal, oxigenación por membrana extracorpórea (ECMO) o bypass cardiopulmonar
• Malformaciones congénitas severas sin expectativa de supervivencia superior a 3 meses
• Pacientes con bacteriemia conocida por S. aureus (MSSA or MRSA)
• Pacientes con osteomielitis, artritis séptica, infección del tracto urinario (ITU) o meningitis
• Pacientes con sospecha de sepsis o sepsis confirmada por gérmenes Gram negativos u hongos
• Otras situaciones en las que el médico considere la necesidad de otro tratamiento empírico
• Participación en otro ensayo clínico o producto de investigación clínica (IMP)

Exclusiones post-aleatorización por el análisis de eficacia
Cualquier paciente con sepsis por gérmenes Gram negativos u hongos, osteomielitis, artritis séptica, infección urinaria, meningitis o bacteriemia por S. aureus (MSSA or MRSA) después de la aleatorización, será excluido del análisis. Aquellos pacientes que recibieron al menos una dosis del vancomicina durante el estudio serán seguidos por razón de seguridad. Si estas exclusiones superan el 10% de los participantes reclutados, existe la opción de reemplazarlos a fin de mantener la integridad del ensayo

E.5 End points

E.5.1

Primary end point(s)

Successful outcome at test of cure visit (TOC) as defined by:
- Participant is alive
AND
- Successful outcome at end of vancomycin therapy (EVT)
AND
- Participant has not had a clinically or microbiologically significant relapse or new infection requiring treatment with vancomycin or other specific anti-staphylococcal antibiotics (flucloxacillin, oxacillin, linezolid, tedizolid, daptomycin and teicoplanin) for more than 24 hours within 10 days of EVT visit

Resultado satisfactorio en la visita de curación (TOC) se define como:
- Paciente vivo
y
- Resultado satisfactorio al terminar el tratamiento con vancomicina (EVT)
y
- Ausencia de recaída clínica o microbiológica o nuevas infecciones que requieran tratamiento con vancomicina u otro antibiótico antiestafilocócico (cloxacilina, oxacilina, linezolid, tedizolid, daptomicina y teicoplanina) por más de 24 horas en los 10 días posteriores a EVT.

E.5.1.1

Timepoint(s) of evaluation of this end point

Test of Cure Visit: 10 +/- 1 days after end of actual vancomycin treatment

Visita de Curación: 10 +/- 1 días después del final del tratamiento en ese momento con vancomicina

E.5.2

Secondary end point(s)

EVALUATION OF EFFICACY
1. Clinically or microbiologically significant relapse or new infection within 10 days of EVT requiring treatment with any antibiotic (other than vancomycin or specific anti-staphylococcal antibiotics) for more than 24
hours
2. Successful outcome at Visit 4 and EVT visit including total duration of vancomycin therapy
3. Clinically or microbiologically significant relapse or new infection at short term follow-up (FU) visit
EVALUATION OF SAFETY
4. Abnormal renal function tests at the short-term FU visit
5. Abnormal hearing screening test
6. Comparative safety of vancomycin (related to all other parameters other than renal and hearing safety) at short-term FU visit
PK/PD EVALUATION
7. PK parameters of vancomycin using population PK modelling by allocation group
8. Probability of target attainment (PTA) with different study regimens
MICROBIOLOGICAL EVALUATION
9. Relationship between CoNS species and duration of treatment and CRP response
10. Gut colonisation by vancomycin resistant organisms at baseline, TOC and short term FU visit
11. Skin colonisation and resistance patterns before and after vancomycin therapy
12. Bacterial DNA PCR analysis in babies ≥ 29 weeks postmenstrual age (PMA)
BIOMARKER EVALUATION
13. Assessment of changes in host biomarker panel profiles from baseline to EVT and the relationship between host biomarker and duration of treatment

EVALUACIÓN DE LA EFICACIA
1. Recaídas clínicas o microbiológicas, nuevas infecciones clínicamente significativas en los 10 días posteriores a la visita EVT, que requieran tratamiento con cualquier otro antibiótico (que no sea vancomicina o antibióticos antiestafilocócico) durante más de 24 horas.
2. Resultado satisfactorio en la visita 4 y EVT incluyendo la duración total del tratamiento con vancomicina.
3. Recaídas y nuevas infecciones clínicamente significativas en el seguimiento a corto plazo.
EVALUACIÓN DE LA SEGURIDAD
4. Alteración de los test de función renal en la visita FU a corto plazo.
5. Alteración del screening auditivo.
6. Seguridad de la vancomicina (en relación a todos aquellos parámetros que no sean la función renal y la audición) a corto plazo en la visita FU.
EVALUACIÓN PK/PD
7. Parámetros PK de la vancomicina usando modelos poblacionales de PK en cada grupo.
8. Probabilidad de cumplimiento de metas (PTA) con los diferentes regímenes de tratamiento en estudio.
EVALUACIÓN MICROBIOLÓGICA
9. Relación entre especies CoNS , duración de tratamiento y respuesta de la PCR.
10. Colonización intestinal por microorganismos resistentes a vancomicina, al inicio, TOC y visita FU a corto plazo.
11. Colonización cutánea y patrones de Resistencia antes y después del tratamiento con vancomicina.
12. Análisis de DNA bacteriano niños en ≥ de 29 semanas de edad postmenstrual (EPM).
EVALUACIÓN DE BIOMARCADORES
13. Evaluación de los cambios en los perfiles de biomarcadores desde el inicio hasta EVT y la relación entre el patrón de los biomarcadores y la duración del tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 10±1 days after the end of vancomycin therapy
2. Day 5±1 or Day 10±2
3. 30±5 days post-initiation of vancomycin therapy
4. 30±5 days post-initiation of vancomycin therapy
5. By Day 90 post-initiation of vancomycin therapy
6. 30±5 days post-initiation of vancomycin therapy
7. End of Trial
8. End of Trial
9. Day 5±1 or Day 10±2
10. Day 0, Day 5±1 or Day 10±2 (for optimised and standard regimens
respectively), 30±5 days post-initiation of therapy
11. 30±5 days post-initiation of therapy
12. Day 0, Day 3 and 30±5 days post-initiation of therapy (measured
retrospectively in batches; no realtime data available)
13. Day 5±1 or Day 10±2

1. 10±1 días después de finalizar en tratamiento con vancomicina
2. Día 5±1 ó día 10±2
3. 30±5 días tras el inicio del tratamiento con vancomicina
4. 30±5 días tras el inicio del tratamiento con vancomicina
5. Para el día 90 tras el inicio del tratamiento con vancomicina
6. 30±5 días tras el inicio del tratamiento con vancomicina
7. Al final del ensayo
8. Al final del ensayo
9. Día 5±1 ó día 10±2
10. Día 0, día 5±1 ó día 10±2 (para la pauta estándar y optimizada respectivamente), 30±5 días tras el inicio del tratamiento
11. 30±5 días tras el inicio del tratamiento
12. Día 0, día 3 y 30±5 días tras el inicio del tratamiento (medido retrospectivamente en los lotes; no disponible datos a tiempo real)
13. Día 5±1 ó día 10±2

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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

Yes

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Same medicinal product but different dosing regimens

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

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

The end of the trial is the date that the database is locked down, this is when all queries have been solved and the database can be released for statistical analyses.

El final del ensayo será la fecha de cierre de la base de datos, es decir cuando todas las queries se hayan resuelto y la base de datos pueda liberarse para el análisis estadístico.

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:

300

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:

105

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

105

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

Neonates and infants more than 3 days, but less than 91 days of age

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

300

F.4.2.2

In the whole clinical trial

300

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)

Vancomycin is an antibiotic that is already being used to treat infections in babies. This study aims to ascertain whether a new regimen of a loading dose followed by a shorter duration of vancomycin is as effective as the regimen which is already being used (no loading dose and longer duration). If a baby required further treatment with vancomycin this would be provided by the neonatal unit as per local guidelines.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	PENTA-ID Network
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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