Clinical Trials Register

Summary
EudraCT Number:	2012-001031-31
Sponsor's Protocol Code Number:	BIPROST
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:	2012-04-17
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

2012-001031-31

A.3

Full title of the trial

Randomized controlled trial of the efficacy of fosfomycin vs ciprofloxacin as antibiotic prophylaxis before transrectal ultrasound guided prostate

Ensayo clínico aleatorizado controlado de la eficacia de fosfomicina vs ciprofloxacino como profilaxis antibiotica previa a biopsia transrectal de próstata ecodirigida

A.3.1

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

Randomized controlled trial of the efficacy of fosfomycin vs ciprofloxacin as antibiotic prophylaxis before transrectal ultrasound guided prostate

Ensayo clínico aleatorizado controlado de la eficacia de fosfomicina vs ciprofloxacino como profilaxis antibiotica previa a biopsia transrectal de próstata ecodirigida

A.3.2

Name or abbreviated title of the trial where available

BIPROST

A.4.1

Sponsor's protocol code number

BIPROST

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 para Formación e Investigación Sanitaria
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 Formación e Investigación Sanitaria
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 para Formación e Investigación Sanitaria
B.5.2	Functional name of contact point	Javier Júdez Gutiérrez
B.5.3	Address:
B.5.3.1	Street Address	C/Luis Fontes Pagán
B.5.3.2	Town/ city	Murcia
B.5.3.3	Post code	30003
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034968359763
B.5.5	Fax number	0034968359777
B.5.6	E-mail	javier.judez@ffis.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	MONUROL 3 g
D.2.1.1.2	Name of the Marketing Authorisation holder	PHARMAZAM, S.A. (Zambon Group)
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	Granules 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	FOSFOMYCIN
D.3.9.1	CAS number	23155-02-4
D.3.9.4	EV Substance Code	SUB07797MIG
D.3.10	Strength
D.3.10.1	Concentration unit	GBq/g gigabecquerel/gram
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: 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	CETRAXAL 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS S.A.L.V.A.T., 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	Buccal 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.3.9.1	CAS number	85721-33-1
D.3.9.3	Other descriptive name	CIPROFLOXACIN
D.3.9.4	EV Substance Code	SUB07470MIG
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/mg megabecquerel(s)/milligram
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	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

urinary sepsis

sepsis urinaria

E.1.1.1

Medical condition in easily understood language

urinary sepsis

sepsis urinaria

E.1.1.2

Therapeutic area

Body processes [G] - Microbiological Phenomena [G06]

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 compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate by using a single dose of fosfomycin 3 g one hour before the biopsy compared to that observed with the use of ciprofloxacin 500 mg 1 hour before the biopsy.

Comparar la incidencia de bacteriuria sintomática o asintomática tras biopsia transrectal de próstata ecodirigida al usar una monodosis de fosfomicina 3 g una hora antes de la biopsia frente a la observada con el uso de ciprofloxacino 500 mg 1 hora antes de la biopsia.

E.2.2

Secondary objectives of the trial

To compare the incidence of genitourinary infection associated with fever (> 38 ° C), incidence of sepsis and other complications after transrectal prostate biopsy under ultrasound guidance by using a single dose of fosfomycin 3 g one hour before the biopsy compared to that observed with the use of ciprofloxacin 500 mg 1 hour before the biopsy.
? Description of the pathogen and resistance observed in the present positive urine cultures was performed on both treatment groups.
? Description of pathogens in positive blood cultures of patients who have undergone a sepsis secondary to biospsia.
? To analyze the association between bacteriuria or urinary tract infection after prostate biopsy and the following variables: age, prostate volume, biopsy results (positive or negative for malignancy) and number of prostate biopsies prior to today.

? Comparar la incidencia de infección genitourinaria asociada a fiebre (>38º C) , incidencia de sepsis y de las distintas complicaciones surgidas tras biopsia transrectal de próstata ecodirigida al usar una monodosis de fosfomicina 3 g una hora antes de la biopsia frente a la observada con el uso de ciprofloxacino 500 mg 1 hora antes de la biopsia.
? Descripción de los patógenos y resistencias observadas presentes en los urocultivos positivos que se realizó a ambos grupos de tratamiento.
? Descripción de patógenos presentes en hemocultivos positivos de los pacientes que hayan padecido un cuadro de sepsis secundaria a la biospsia.
? Analizar la asociación entre bacteriuria o infección del tracto urinario tras biopsia prostática y las siguientes variables: edad, volumen de la prostata, resultado de la biopsia (positiva o negativa para neoplasia maligna) y número de biopsias prostáticas anteriores a la actual.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Age over 18 years.
? A patient who attends hospital outpatient biopsy protática by PSA over 4 ng / ml or suspicious digital rectal tumor.
? Subjects who have given written informed consent to participate in the study.

? Edad mayor de 18 años.
? Paciente que acude a consulta externa de hospital para biopsia protática por antígeno prostatico mayor de 4 ng/ml o por tacto rectal sospechoso de tumor.
? Sujetos que hayan otorgado el consentimiento informado por escrito para participar en el estudio.

E.4

Principal exclusion criteria

? History (confirmed or suspected) allergy to any of the drugs included in the study.
? History (confirmed or suspected) of intolerance to any of the drugs included in the study.
? Presence of urinary tract infection confirmed by urine culture or urinalysis.
? Clinical findings suggestive of infection (any origin).
? Antibiotic therapy in the last 4 weeks.
? Patient carrier catheter.

? Historia (confirmada o sopecha) de alergia a alguno de los fármacos incluidos en el estudio.
? Historia (confirmada o sospecha) de intolerancia a alguno de los fármacos incluidos en el estudio.
? Presencia de infección urinaria confirmada por urocultivo o análisis de orina.
? Hallazgos clínicos que sugieran infección (de cualquier origen).
? Tratamiento antibiótico en las últimas 4 semanas.
? Paciente portador de sonda vesical.

E.5 End points

E.5.1

Primary end point(s)

? Bacteriuria. Appearance in the urine culture of a significant number of bacteria (> 105 cfu / ml).

? Bacteriuria. Aparición en el cultivo de orina de un número significativo de bacterias (>105 ufc/ml).

E.5.1.1

Timepoint(s) of evaluation of this end point

-Dia 25 post-biopsia prostatica

Day 25 post-biopsy protatic

E.5.2

Secondary end point(s)

? Urinary tract infection
? Genitourinary infections associated with fever (> 38 ° C)
? Sepsis.
? Pathogens present in urine and their sensitivity to antibiotics
? Bacteremia
? Clinical and demographic variables

? Infección del tracto urinario
? Infecciones genitourinarias asociadas a fiebre (>38ºC)
? Sepsis.
? Patógenos presentes en urocultivos y su sensibilidad a antibióticos
? Bacteriemia
? Variables clínico-demográficas

E.5.2.1

Timepoint(s) of evaluation of this end point

These variables are meseaure when the patients develope the nexts tipe infection:

? Urinary tract infection
? Genitourinary infections associated with fever (> 38 ° C)
? Sepsis.
? Pathogens present in urine and their sensitivity to antibiotics
? Bacteremia

This Varibles is measure in day 0:

? Clinical and demographic variables

Las siguientes variables seran medidas cuando se desarrolle alguna de las infecciones siguientes:

? Urinary tract infection
? Genitourinary infections associated with fever (> 38 ° C)
? Sepsis.
? Pathogens present in urine and their sensitivity to antibiotics
? Bacteremia

Esta variables se medirá en el dia 0:
? Clinical and demographic variables

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

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

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

The last patient last visit

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:

400

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

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

470

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)

The plan of treatment is not different from the expected normal treatment of that condition

El plan de tratamiento una vez que haya terminado el ensayo no es distinto a la practica habitual

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

2012-06-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-28

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

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