Clinical Trials Register

Summary
EudraCT Number:	2021-003376-14
Sponsor's Protocol Code Number:	1
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:	2021-12-02
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

2021-003376-14

A.3

Full title of the trial

Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula. A randomized, double-blind clinical trial.

Ensayo clínico randomizado, doble ciego, controlado con placebo, para evaluar la eficacia de la antibioterapia con amoxicilina/clavulánico tras el drenaje quirúrgico del absceso perianal en la prevención del desarrollo de fístula perinanal.

A.3.1

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

Amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula.

Amoxicilina/clavulánico tras el drenaje quirúrgico del absceso perianal en la prevención del desarrollo de fístula perinanal.

A.4.1

Sponsor's protocol code number

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	Mariano Artes Caselles
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 para la Investigación Biomédica Puerta de Hierro
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	Hospital Universitario Puerta de Hierro Majadahonda
B.5.2	Functional name of contact point	Hospital Universitario Puerta de Hi
B.5.3	Address:
B.5.3.1	Street Address	C/ Manuel de Falla, 1
B.5.3.2	Town/ city	Majadahonda
B.5.3.3	Post code	28222
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034911916480
B.5.6	E-mail	bruizantoran@gmail.com

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	AMOXICILINA-CLAVULÁNICO
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
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

perianal abscess

Absceso perianal

E.1.1.1

Medical condition in easily understood language

perianal abscess

Absceso perianal

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

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 determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.

Determinar la eficacia de la antibioterapia tras el drenaje quirúrgico del absceso perianal en el desarrollo de fístula perianal.

E.2.2

Secondary objectives of the trial

-Identify the time elapsed until the appearance of perianal fistula and its complexity according to the St James classification.
-Identify relapses in the follow-up and the need for re-surgery surgery
-Assess the impact on the quality of life of these patients.
-Evaluate safety and tolerability

-Identificar el tiempo transcurrido hasta la aparición de fístula perianal y su complejidad según la clasificación de St James.
-Identificar recaídas en el seguimiento y necesidad de cirugía de re-cirugía
-Valorar la afectación de la calidad de vida de estos pacientes.
-Evaluar seguridad y tolerabilidad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Men and women> 18 years
2. First episode of perianal abscess.
3.Tolerance to oral diet.
4. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Signature of the written informed consent in accordance with ICH / GCP and local legislation, obtained before any study procedure.

1.Hombres y mujeres >18 años
2.Primer episodio de absceso perianal.
3.Tolerancia a dieta por vía oral.
4.Voluntad y capacidad para cumplir con las visitas programadas, plan de tratamiento, análisis de laboratorio y otros procedimientos del estudio.
5.Firma del consentimiento informado escrito conforme a ICH/GCP y a la legislación local, obtenido antes de cualquier procedimiento de estudio.

E.4

Principal exclusion criteria

1. Allergy or intolerance to beta-lactams.
2. Contraindication to the performance of any of the study procedures.
3. History of previous perianal surgery (EABA, episiotomy, etc.).
4. Any clinical condition, and / or analytical alteration that, in the opinion of the investigator, is considered clinically significant to participate in the study. The following are considered as such:
a) Previous or diagnosed perianal fistula during surgery.
b) Complex abscess (horseshoe, supraelevator ...).
c) Marked cellulite after surgical drainage.
d) History of inflammatory bowel disease.
e) History of anal cancer.
f) Previous trauma or radiotherapy.
g) Diabetes mellitus.
h) Immunosuppressed: cancer patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease.
i) Valve prosthesis.
j) Morbid obesity (BMI> 40).
k) Signs of severe sepsis.

5. Women with positive pregnancy test results or breastfeeding.
6. Lack of will or inability to follow the procedures described in the protocol.
7. Inability to give written informed consent.

1.Alergia o intolerancia a betalactámicos.
2.Contraindicación para la realización de alguno de los procedimientos del estudio.
3.Antecedente de cirugía previa perianal (EABA, episiotomía, etc.).
4.Cualquier condición clínica, y/o alteración analítica que, a juicio del investigador, sea considerada clínicamente significativa como para participar en el estudio. Se consideran como tales las siguientes:
a)Fístula perianal previa o diagnosticada durante la cirugía.
b)Absceso complejo (en herradura, supraelevador…).
c)Celulitis marcada tras drenaje quirúrgico.
d)Antecedentes de enfermedad inflamatoria intestinal.
e)Antecedentes cáncer de ano.
f)Traumatismo o radioterapia previa.
g)Diabetes mellitus.
h)Inmunodeprimidos: pacientes oncológicos, tratamiento corticoideo crónico u otros inmunosupresores, enfermedad renal crónica.
i)Prótesis valvular.
j)Obesidad mórbida (IMC>40).
k)Signos de sepsis grave.

5.Mujeres con resultados positivos de la prueba de embarazo o en periodo de lactancia.
6.Falta de voluntad o incapacidad para seguir los procedimientos descritos en el protocolo.
7.Incapacidad para otorgar el consentimiento informado por escrito.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients who develop perianal fistula.

Porcentaje de pacientes que desarrollan fístula perianal.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months

6 meses

E.5.2

Secondary end point(s)

-Time elapsed until fistula appearance (months).
-Complexity of the fistula according to the St James classification in imaging tests.
-Presence of a new episode of perianal abscess in the follow-up.
-Need for scheduled surgery for perianal fistula treatment (number of interventions, time elapsed since the initial event and technique used)
-Quality of life questionnaire after the appearance of the perianal fistula (QoLAF-Q questionnaire).

-Tiempo transcurrido hasta aparición fístula (meses).
-Complejidad de la fístula según la clasificación de St James en prueba imagen.
-Presencia de nuevo episodio de absceso perianal en el seguimiento.
-Necesidad de cirugía programada para tratamiento fístula perianal (número de intervenciones, tiempo transcurrido desde el evento inicial y técnica utilizada)
-Cuestionario calidad de vida tras la aparición de la fístula perianal (cuestionario QoLAF-Q).

E.5.2.1

Timepoint(s) of evaluation of this end point

Days 30, 90 and 180

Días 30, 90 y 180

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

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

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

Visita fin de estudio del último paciente incluido

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:

200

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

286

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)

Usual care

Práctica clínica

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

2021-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-04

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

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