Clinical Trials Register

Summary
EudraCT Number:	2021-002911-72
Sponsor's Protocol Code Number:	EfFoCa2021
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:	2021-12-22
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

2021-002911-72

A.3

Full title of the trial

A randomized, double blind, double dummy, parallel group, multicenter clinical trial to evaluate the safety and clinical and microbiologic efficacy of oral fosfomycin calcium in adult women with uUTI.

Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos para evaluar la seguridad y la eficacia clínica y microbiológica de fosfomicina cálcica oral en mujeres adultas con infección no complicada del tracto urinario.

A.3.1

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

A.4.1

Sponsor's protocol code number

EfFoCa2021

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	Laboratorios ERN, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Laboratorios ERN, S.A.
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	Bioaraba
B.5.2	Functional name of contact point	Unidad de Ensayos Clínicos
B.5.3	Address:
B.5.3.1	Street Address	José Atxotegi, s/n
B.5.3.2	Town/ city	Vitoria-Gasteiz
B.5.3.3	Post code	01009
B.5.3.4	Country	Spain
B.5.4	Telephone number	349450070007491
B.5.6	E-mail	zurine.abajoalda@osakidetza.eus

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	Fosfocina (R) 500 mg. cápsulas
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios ERN, 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.3.1	Product name	Fosfocina (R) 500 mg. cápsulas
D.3.4	Pharmaceutical form	Capsule, hard
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 CALCIUM
D.3.9.1	CAS number	26016-98-8
D.3.9.4	EV Substance Code	SUB02261MIG
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	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	Danifos Adulti 3g. GRANULATO PER SOLUZIONE ORALE
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios La.Fa.Re. S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Danifos Adulti 3g. GRANULATO PER SOLUZIONE ORALE
D.3.4	Pharmaceutical form	Granules for oral suspension
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.3.9.3	Other descriptive name	fosfomycin trometamol
D.3.9.4	EV Substance Code	SUB02263MIG
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	3000
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	Granules for oral solution in sachet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Uncomplicated cysititis in women

Infecciones de orina no complicadas en mujeres

E.1.1.1

Medical condition in easily understood language

Uncomplicated cysititis in women

Infecciones de orina no complicadas en mujeres

E.1.1.2

Therapeutic area

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

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 assess that the efficacy of fosfomycin calcium in the clinical and microbiological resolution of the uUTI in women is non-inferiority to the efficacy of fosfomycin trometamol.

Evaluar que la eficacia de la fosfomicina cálcica en la resolución clínica y microbiológica de la infección de orina no complicada en mujeres es no inferior a la eficacia de la fosfomicina trometamol.

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to monitor the safety and tolerability of the dose regimen of oral fosfomycin calcium capsules when administered in adult women with uUTI.

El objetivo secundario de este estudio es controlar la seguridad y la tolerabilidad del régimen de dosis de las cápsulas orales de fosfomicina cálcica cuando se administran en mujeres adultas con IU.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Adult women (≥18 years) with initial uncomplicated urinary tract infection (uUTI).

• Must have ≥ two of the following signs of uUTI:
o Urinary frecuency
o Urinary urgency
o Dysuria (pain of burning on urination)
o Suprapubic pain

• Mid-stream urine specimen with dipstick analysis positive for both:
o Nitrite.
o Leukocyte esterase (evidence of pyuria)

• Using effective barrier contraception (there will be a pregnancy test by determining urine β-HCG levels in Visit 0)

• Subject able to communicate effectively and provide written informed consent.

Mujeres adultas mayores de 18 años con infección del tracto urinario no complicada

Debe tener al menos dos de los siguientes signos de infección del tracto urinario no complicada
-. Frecuencia urinaria
-. Urgencia urinaria
-. Disuria ( dolor o quemazón en la micción)
-. Dolor suprapúbico

Muestra de orina a mitad de micción con análisis de tira reactiva positivo para ambos:
-. Nitritos
-. Esterasa leucocitaria (evidencia de piuria)

- Utilización de métodos anticonceptivos de barrera eficaces (se realizará una prueba de embarazo mediante la determinación de los niveles de β-HCG en orina en la Visita 0)
- Sujeto capaz de comunicarse eficazmente y dar su consentimiento informado por escrito.

E.4

Principal exclusion criteria

• Clinical evidence of renal pathology (fever and renal first percussion positive…).

• Patients with galactose intolerance, with glucose-galactose malabsorption or with insufficiency of sucrase isomaltase

• Women with gynaecological infections and cUTI.

• Pregnant or nursing woman.

• Taking part in another clinical trial during the two months prior to the current trial.

-. Evidencia clínica de patología renal (fiebre y primera percusión renal positiva...).

- Pacientes con intolerancia a la galactosa, con malabsorción de glucosa-galactosa o con insuficiencia de sucasa isomaltosa.

- Mujeres con infecciones ginecológicas e infecciones del tracto urinario complicadas.

- Mujeres embarazadas o en periodo de lactancia.

- Participar en otro ensayo clínico durante los dos meses anteriores al ensayo actual.

E.5 End points

E.5.1

Primary end point(s)

Clinical (resolution of symptoms of uUTI) and microbiological response (bacterial pathogen reduced to <103 CFU/mL. in urine culture) in the microbiological-ITT population

Respuesta clínica (resolución de los síntomas de la infección de orina) y microbiológica (reducción del patógeno bacteriano a <103 UFC/mL. en el cultivo de orina) en población microbiológica con intención a tratar

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit)

Proporción de sujetos con éxito clínico y microbiológico continuado evaluado en la Visita 1 (Visita TOC)

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 1 (TOC visit)

Visita 1 (Visita TOC)

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

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)

Yes

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

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)

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

Última visita del último sujeto

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:

360

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

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-22.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

384

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

Ninguna

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-03-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-03

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

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