Clinical Trials Register

Summary
EudraCT Number:	2019-002002-43
Sponsor's Protocol Code Number:	INMEPREP-2019
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:	2019-10-21
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

2019-002002-43

A.3

Full title of the trial

Phase IV, unicentric, randomized and open study to confirm the decrease of the incidence of the surgical site infection after elective right hemicolectomy with anterographic mechanical preparation associated with oral and intravenous antibiotic therapy versus oral and intravenous antibiotic and versus only intravenous antibiotic

Estudio fase IV, unicéntrico, aleatorizado y abierto para confirmar la disminución de la incidencia de infección del sitio quirúrgico tras hemicolectomía derecha electiva con preparación mecánica anterógrada asociada a antibioterapia oral e intravenosa frente a antibioterapia oral e intravenosa y únicamente intravenosa.

A.3.1

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

Randomized study of three treatment arms; Colon mechanical preparation with oral and intravenous antibiotics versus oral and intravenous or only intravenous antibiotics. To confirm the decrease of infections in the surgical site with the first of the treatment arm after colon surgery.

Estudio aleatorizado de tres ramas de tratamiento; Preparación mecánica del cólon junto con antibioticos orales e intravenosos frente a antibioóicos orales e intravenosos o únicamente intravenosos. Para confirmar la disminución de infecciones en el sitio quirúrgico con la primera de las ramas de tratamiento tras intervención quirúrgica de colon.

A.4.1

Sponsor's protocol code number

INMEPREP-2019

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	Fundación Instituto de Investigación Sanitaria Aragón
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	Fundación Instituto de Investigación Sanitaria Aragón
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	Fundación Instituto de Investigación Sanitaria Aragón
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	Avda/ San Juan Bosco 13, Edificio CIBA, IIS Aragon, Planta Baja
B.5.3.2	Town/ city	Zaragoza
B.5.3.3	Post code	50009
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034976713259
B.5.6	E-mail	pmillan@iisaragon.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	CitraFleet
D.2.1.1.2	Name of the Marketing Authorisation holder	Casen Recordati, S.L.,
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.3.4	Pharmaceutical form	Concentrate for oral solution
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	SODIUM PICOSULFATE
D.3.9.1	CAS number	10040-45-6
D.3.9.4	EV Substance Code	SUB10569MIG
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM OXIDE
D.3.9.1	CAS number	546-93-0
D.3.9.3	Other descriptive name	MAGNESIUM OXIDE, LIGHT
D.3.9.4	EV Substance Code	SUB12130MIG
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	3.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CITRIC ACID ANHYDROUS
D.3.9.1	CAS number	77-92-9
D.3.9.3	Other descriptive name	CITRIC ACID ANHYDROUS
D.3.9.4	EV Substance Code	SUB29050
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	10.97
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.2.1.1.1	Trade name	Eritromicina
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS NORMON, 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.3.4	Pharmaceutical form	Coated 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	ERYTHROMYCIN
D.3.9.1	CAS number	41342-53-4
D.3.9.3	Other descriptive name	ERYTHROMYCIN ETHYLSUCCINATE
D.3.9.4	EV Substance Code	SUB01942MIG
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	1
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.2.1.1.1	Trade name	Neomicina
D.2.1.1.2	Name of the Marketing Authorisation holder	S.A.L.V.A.T.
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.3.4	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	NEOMYCIN SULFATE
D.3.9.1	CAS number	1405-10-3
D.3.9.3	Other descriptive name	NEOMYCIN SULFATE
D.3.9.4	EV Substance Code	SUB03409MIG
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	1
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

Patients undergoing right hemicolectomy

Pacientes sometidos a hemicolectomía derecha

E.1.1.1

Medical condition in easily understood language

Patients who are going to have surgery on the colon

Pacientes que van a ser intervenidos quirúrgicamente de colon

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10039153
E.1.2	Term	Right hemicolectomy
E.1.2	System Organ Class	100000004865

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 in terms of surgical site infection reduction for the use of oral and intravenous antibiotic prophylaxis associated with mechanical preparation of the colon, compared with the use of antibiotic only intravenously or the association of antibiotic therapy oral and intravenous without mechanical preparation, in the surgical procedure of right hemicolectomy.

Establecer la eficacia en términos de reducción de infección de sitio quirúrgico del uso de profilaxis antibiótica (AB) vía oral e intravenosa asociado a preparación mecánica del colon, en comparación con el uso de AB únicamente por vía intravenosa (IV) o la asociación de antibioterapia oral e intravenosa sin PMC, en el procedimiento quirúrgico de hemicolectomía derecha.

E.2.2

Secondary objectives of the trial

Assess differences between the three groups in relation to anastomotic dehiscence rate
Assess differences between the three groups in relation to post-surgical hospital stay
Assess differences between the three groups in relation to global complications in the immediate postoperative period

Valorar diferencias entre los tres grupos en relación a tasa de dehiscencia anastomótica
Valorar diferencias entre los tres grupos en relación a estancia hospitalaria postquirúrgica
Valorar diferencias entre los tres grupos en relación a complicaciones globales en el
postoperatorio inmediato

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients older than 18 years with surgical indication of right hemicolectomy who do not present any exclusion criteria.

Pacientes mayores de 18 años con indicación quirúrgica de hemicolectomía derecha que no
presenten ningún criterio de exclusión.

E.4

Principal exclusion criteria

1. Patients under 18 years.
2. Urgent colorectal resections.
3. Patients presenting an occlusive or sub-occlusive condition at the time of surgery.
4. Patient who does not meet the inclusion criteria in the intensified recovery program based on the RICA route (Intensified Recovery in Abdominal Surgery)
5. Patients undergoing colonic resection that involve a location other than the right colon.
6. Patients affected by intra-abdominal or distant infection prior to surgery.
7. Patients who have been given antibiotics for any other indication during the two weeks prior to the intervention.
8. Patient with inflammatory bowel disease.
9. Pregnant or breastfeeding patient.
10. Patients with immunity disorders or receiving immunosuppressive treatment or with synchronous neoplasms of other organs at the time of surgery.
11. Previous history of allergy to erythromycin, neomycin or derivatives, as well as Citrafleet®.

1. Pacientes menores de 18 años.
2. Resecciones colorrectales de carácter urgente.
3. Pacientes que presenten un cuadro oclusivo o suboclusivo en el momento de la cirugía.
4. Paciente que no cumpla criterios de inclusión en el programa de recuperación intensificada basado en la vía RICA (Recuperación Intensificada en Cirugía Abdominal)
5. Pacientes sometidos a resección colónicas que impliquen otra localización diferente a colon derecho.
6. Pacientes afectados por infección intraabdominal o a distancia previa a la cirugía.
7. Pacientes a los que se ha administrado antibiótico por cualquier otra indicación durante las dos semanas previas a la intervención.
8. Paciente portador de enfermedad inflamatoria intestinal.
9. Paciente embarazada o en periodo de lactancia.
10. Pacientes con alteraciones de la inmunidad o que reciban tratamiento inmunosupresor o con neoplasias sincrónicas de otros órganos en el momento de la cirugía.
11. Historia previa de alergia a la eritromicina, neomicina o derivados, así como a Citrafleet®.

E.5 End points

E.5.1

Primary end point(s)

Temperature
Appearance of surgical wound
Abdominal examination
C-reactive protein
Surgical wound culture

Temperatura
Aspecto de la herida quirúrgica
Exploración abdominal
Proteína C Reactiva
Cultivo de herida quirúrgica

E.5.1.1

Timepoint(s) of evaluation of this end point

daily up to 30 days after surgery

Diariamente hasta 30 días tras la cirugia

E.5.2

Secondary end point(s)

Anastomotic dehiscence rate
Duration of the post-surgical hospital stay
Global Complication Rate

Tasa de dehiscencia Anastomótica
Duración de la Estancia hospitalaria postquirúrgica
Tasa de Complicaciones globales

E.5.2.1

Timepoint(s) of evaluation of this end point

For 30 days after surgery

Durante 30 días tras la cirugía

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

Yes

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

Yes

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)

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

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

Última visita del último paciente

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:

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

108

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)

None

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

2019-12-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-12

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

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