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    Summary
    EudraCT Number:2019-003792-19
    Sponsor's Protocol Code Number:FOS-PROST-001
    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:2024-12-02
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003792-19
    A.3Full title of the trial
    Fosfomycin as an oral alternative treatment for acute bacterial prostatitis due to multi-drug resistant Escherichia coli. Pilot study
    Fosfomicina como terapia alternativa por vía oral en el tratamiento de prostatitis aguda bacteriana por Escherichia coli multirresistente. Estudio piloto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fosfomycin as an oral alternative treatment for acute bacterial prostatitis due to multi-drug resistant Escherichia coli
    Fosfomicina como alternativa oral en el tratamiento de prostatitis aguda bacteriana por Escherichia coli multirresistente
    A.4.1Sponsor's protocol code numberFOS-PROST-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospital Universitari Mutua Terrassa
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundació Docencia i Recerca Mútua Terrassa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica en Enfermedades Infecciosas
    B.5.2Functional name of contact pointUIMI
    B.5.3 Address:
    B.5.3.1Street AddressPlaza Doctor Robert, 5
    B.5.3.2Town/ cityTerrassa/Barcelona
    B.5.3.3Post code08221
    B.5.3.4CountrySpain
    B.5.4Telephone number+34606049845
    B.5.5Fax number+34937365037
    B.5.6E-mailcbadia@mutuaterrassa.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name FOSFOMICINA QUALIGEN 3 g GRANULADO PARA SOLUCION ORAL EFG, caja de 2 sobres
    D.2.1.1.2Name of the Marketing Authorisation holderNEURAXPHARM SPAIN, S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFosfomicina-trometamol
    D.3.4Pharmaceutical form Granules for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOSFOMYCIN TROMETAMOL
    D.3.9.3Other descriptive nameFOSFOMYCIN
    D.3.9.4EV Substance CodeSUB02263MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Acute bacterial prostatitis due to multi-drug resistant Escherichia coli
    Prostatitis aguda bacteriana por Escherichia coli multirresistente
    E.1.1.1Medical condition in easily understood language
    Acute prostatitis
    Prostatitis aguda
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess clinical and microbiological cure in patients with acute bacterial prostatitis due to multi-drug resistant Escherichia coli treated with oral fosfomycin-trometamol
    Determinar la eficacia del tratamiento secuencial con fosfomicina-trometamol (FT) por vía oral de las prostatitis agudas por E. coli multiresistente (MR) con sensibilidad in vitro a la fosfomicina en pacientes con estabilidad clínica y que hayan recibido entre 2 y 5 días de antibioterapia previa con un antimicrobiano con actividad in vitro.
    E.2.2Secondary objectives of the trial
    - Assessment of use of carbapenems.
    - Assessment of length of stay.
    - Pharmacokinetic study.
    - Determinar, comparando con una cohorte histórica, el uso de carbapenémicos en DDD por episodio de ITU.

    - Determinar, comparando con una cohorte histórica, la duración del ingreso hospitalario o ingreso en régimen de hospitalización a domicilio.

    - Estudiar la farmacocinética de la FT por vía oral a través de la determinación de niveles en sangre.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male adult patients (18 years of age or older) with acute prostatitis due to multi-drug resistant (MDR) Escherichia coli susceptible to fosfomycin.

    Diagnosis of prostatitis requires prostatic-specific antigen (PSA) elevation> 4 μg/L and the presence of at least one microbiological criterion and two clinical criteria among the following:

    Microbiological criteria (at least 1):

    Urine culture with >100,000 cfu/mL of MDR E. coli with MIC to fosfomycin <=32 mg/L.
    Positive blood culture by MDR E. coli with MIC to fosfomycin <32 mg/L, with clinical data of sepsis without another evident or probable origin of bacteremia more than the urinary and presence of pyuria (≥10 leukocytes / mm3 or positive leukocyte esterase in urine strip).
    Clinical criteria (at least 2):

    Presence of any symptoms of the lower urinary tract:

    Irritative symptoms: urgency, urinary frequency, dysuria or tenesmus.
    Obstructive symptoms: difficulty in voiding onset, decreased calibre, post-void residue or acute urinary retention)
    Spontaneous perineal pain or during urination.

    Pain referred to the suprapubic, perineal, lumbosacral, scrotal, penile or inner thigh areas.
    Enlarged, increased temperature and painful prostate on the digital rectal examination.
    History of prostatic disease (prostate neoplasm, benign prostatic hypertrophy) and:

    History of recent manipulation of the urinary tract.
    Recent history (<7 days) of transrectal prostate biopsy.
    Decrease in the level of consciousness in elderly patients (> 70 years) with no other apparent cause.
    Varones adultos (18 años o más) con prostatitis aguda bacteriana, febril, por E. coli mutlirresistente sensible a fosfomicina (ver definiciones más adelante). El diagnóstico de prostatitis requiere la elevación del PSA > 4 μg/L y la presencia de al menos un criterio microbiológico y dos criterios clínicos entre los siguientes:

    Criterios microbiológicos (al menos 1):
    (1) Urinocultivo con más de 100.000 ufc/mL de E. coli multirresistente con CMI a la fosfomicina < =32 mg/L.
    (2) Hemocultivo positivo por E. coli multirresistente con CMI a la fosfomicina < 32 mg/L, con datos clínicos de sepsis sin otro origen evidente o probable de la bacteriemia más que el urinario y presencia de piuria (≥10 leucocitos/mm3 o esterasa leucocitaria positiva en tira de orina).
    Criterios clínicos (al menos 2):
    1. Presencia de algún síntoma del tracto urinario inferior:
    - Síntomas irritativos: urgencia miccional, polaquiuria, disuria o tenesmo.
    - Síntomas obstructivos: dificultad de inicio miccional, calibre disminuido, residuo postmiccional o retención aguda de orina)
    2. Dolor perineal espontáneo o a la micción.
    - Dolor referido a área suprapúbica, perineal, lumbosacra, escrotal, peneana o cara interna de muslos.
    - Tacto rectal con próstata agrandada, aumentada de Tª y dolorosa.
    3. Antecedentes de enfermedad prostática (neoplasia de próstata, hipertrofia benigna de próstata) y:
    - Historia de manipulación reciente de la vía urinaria.
    - Antecedente reciente (<7 días) de biopsia prostática transrectal.
    - Disminución del nivel de consciencia en pacientes ancianos (> 70 años) sin otra causa aparente.
    E.4Principal exclusion criteria
    - Allergy or known intolerance to fosfomycin.
    - Polymicrobial bacteria or urine culture.
    - Clinical criteria of acute pyelonephritis (fist-positive renal percussion, obstruction of the urinary tract, abscess renal).
    - Anatomical alterations of the urinary tract.
    - Urinary infections associated with urinary catheters.
    - Undrained prostatic abscess.
    - Another concomitant infection.
    - Patients who have not reached clinical stability after 5 days of parenteral treatment.
    - Patients with septic shock at the time of randomization.
    - Polycystic kidney disease.
    - History of chronic prostatitis.
    - Immunosuppressed patients (kidney transplant, liver cirrhosis, patients on renal replacement therapy, chronic treatment with corticosteroids, which receive active chemotherapy, use of anti-TNF)
    - Terminal situation or estimated life expectancy of less than 90 days or in purely palliative treatment of their base disease.
    - Patients who are participating in another clinical trial with active treatment.
    - MIC to fosfomycin superior to that established by the inclusion criteria of the study.
    - Patients who refuse to give consent to participate in the study.
    - Alergia o intolerancia conocida a la fosfomicina.
    - Bacteriemia o urocultivo polimicrobianos
    - Criterios clínicos de pielonefritis aguda (puño-percusión renal positiva, obstrucción de la vía urinaria, absceso renal).
    - Alteraciones anatómicas de las vías urinarias
    - Infecciones urinarias asociadas a catéteres urinarios.
    - Absceso prostático no drenado.
    - Otra infección concomitante.
    - Pacientes que no hayan alcanzado la estabilidad clínica después de 5 días de tratamiento parenteral.
    - Pacientes con shock séptico en el momento de la aleatorización.
    - Poliquistosis renal.
    - Historia de prostatitis crónica.
    - Pacientes inmunodeprimidos (trasplantados renales, cirrosis hepática, pacientes en terapia de sustitución renal, tratamiento crónico con corticoides, que reciben quimioterapia activa, uso de antiTNF)
    - Situación terminal o esperanza de vida estimada inferior a 90 días o en tratamiento puramente paliativo de su enfermedad de base.
    - Pacientes que estén participando en otro ensayo clínico con tratamiento activo.
    - CMI a fosfomicina superior a la establecida por los criterios de inclusión del estudio.
    - Pacientes que rechacen dar el consentimiento para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Clinical cure will be assess by a clinical team as the resolution of all symptoms of prostatitis that were present at the time of diagnosis (fever, symptoms of the lower urinary tract (irritative sypmtoms: urgency, urinary frequency...) and perineal pain (spontaneous or during urination).

    - Microbiological cure requires negative urine culture at days 5-7 after the EOT.
    - Curación clínica: resolución de todos los síntomas del paciente presentes en el momento del diagnóstico. Además, el paciente no debe presentar ninguno de los siguientes: fiebre, síntomas urinarios (disuria, polaquiuria, urgencia miccional) o dolor suprapúbico.

    - Curación microbiológica: Se definirá como la obtención de un urinocultivo negativo a los 7 días (+/- 3 días) de finalización del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Clinical cure: at the end of therapy (21 +/- 5 days).

    - Microbiological cure: 7 days (+/- 3 days) after EoT.
    - Curación clínica: al final de tratamiento (FdT) 21 +/-5 días.

    - Curación microbiológica: 7 días +/- 3 días de final de tratamiento.
    E.5.2Secondary end point(s)
    - Carbapenemic DDD per 100 stays in the experimental group versus the control group.

    - Length of hospital stay (days) in the experimental group versus the control group.

    - Fosfomycin pharmacokinetic parameters ([Cmax], [Cmin], AUC, clearance, volume of distribution).
    - DDD de carbapenémicos por 100 estancias en el grupo experimental frente al grupo control.

    - Duración de la estancia hospitalaria (días) en el grupo experimental frente al grupo control.

    - Parámetros farmacocinéticos de fosfomicina ([Cmax], [Cmin], ABC, aclaramiento, volumen de distribución).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 6 months after the end of recruitment period.
    - 6 meses después de finalizar el reclutamiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Grupo control: cohorte histórica retrospectiva
    Control group will be a retrospective historic cohort
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 (46-56 days after EoT of last patient recruited)
    Última visita del último paciente reclutado (46-56 días de FdT).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state122
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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