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    Summary
    EudraCT Number:2012-001916-41
    Sponsor's Protocol Code Number:C11-11
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-02-09
    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 number2012-001916-41
    A.3Full title of the trial
    Fluconazole versus Micafungin in neonates with suspected or culture-proven Candidiasis: a randomized pharmacokinetic and safety study
    Fluconazol frente a micafungina en neonatos con candidiasis o sospecha por cultivo: estudio randomizado de fármacocinética y seguridad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fluconazole and micafungin in neonates
    Fluconazol frente a micafungina en neonatos
    A.3.2Name or abbreviated title of the trial where available
    Fluconazole versus Micafungin in neonates
    Fuconazol frente a micafungina en neonatos
    A.4.1Sponsor's protocol code numberC11-11
    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 SponsorInserm
    B.1.3.4CountryFrance
    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 supportCommission Européenne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUICEC-IBIMA
    B.5.2Functional name of contact pointGloria Luque
    B.5.3 Address:
    B.5.3.1Street AddressAvda Carlos Haya, s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number34951291977
    B.5.5Fax number34951440263
    B.5.6E-mailgloria.luque.exts@juntadeandalucia.es
    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 Fluconazole
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi France
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.IMP: 2
    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 Micamicine
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europ BV
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Neonates with suspected or culture-proven candidiasis
    Neonatos con sospecha de candidiasis o cultivo positivo
    E.1.1.1Medical condition in easily understood language
    Neonates with suspected or culture-proven candidiasis
    Neonatos con sospecha de candidiasis o cultivo positivo
    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 evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage
    To compare the time to reach the target drug exposure area under the concentration-time curve from 0 to 24 h (AUC0?24) for candidiasis by the two randomly administered drugs.
    Evaluar la farmacocinética de fluconazol y micafungina tras la randi¡omización en neonatos con sospecha de candidiasis o cultivo positivo para evaluar la mejor dosis.
    Compararel tiempo para alcanzar el área de exposición al medicamento bajo una curva de concentración de 0 a 24 h (AUC0?24) para candidiasis de los dos fármacos randomizados.
    E.2.2Secondary objectives of the trial
    To evaluate the tolerability of fluconazole and micafungin in neonates with suspected or culture-proven Candidiasis

    To describe short-term safety

    To describe short term outcome of treated episodes
    Evaluar la tolerabilidad de fluconazol y micafungina en neonatos con sospecha de candidiasis o cultivo positivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Neonates and infant between 24 up to 42 weeks gestational age and with post natal age of 48 hours of life up to day of life (DOL) 120 at the time of culture acquisition.
    - Requiring antifungal therapy according to medical decision by attending physician for microbiologically documented and clinically suspected candida infection independently from the availability of any positive culture for Candida spp.
    - Written informed consent from the parents or the legally authorized representative must be obtained prior to entry.
    - Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
    - Neonatos y niños entre 24 y 42 semanas de gestación con una edad postnatal de 48 horas de vida (DOL) en el momento de la toma de los cultivos.
    - Que requieran tratamiento antifúngico según criterio médico o fundamento microbiológico y sospecha clínica de candidiasis con un cultivo positivo a cándida.
    - Consentimiento escrito de los padres o representantes legales antes del comienzo del ensayo.
    - El niño debe tener un acceso venoso aceptable que permita la administración de la medicación del estudio y la monitorización de las variables de seguridad.
    E.4Principal exclusion criteria
    - Infant exposed to fluconazole or micafungin prophylaxis prior to inclusion
    - Infant who has received more than 48hours of systemic antifungal therapy (any product) prior to the first dose of study drug for treatment of the current Candida infection
    - Infant with a concomitant medical condition, whose participation, in the opinion of the investigator and / or medical advisor, may create an unacceptable additional risk
    - Infant previoulsy enrolled in this study
    - Infant who is co-infected with a non-Candida fungal organism
    - Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or fluconazole product.
    - Infant with pre existing hepatic or renal disease
    - Niños que ya han recibido profilaxis con fluconazol o micafungina antes de la inclusión.
    - Niños que hayan recibido antifúngicos sistémicos (cualquiera)durante más de 48h por una infección por cándida.
    - Niños con otra patología concomitante que a criterio de médico o investigador pueda hacer que el participar en el ensayo le suponga un riesgo inaceptable.
    - Niños incluidos anteriormente en este estudio.
    - Niños co-infectado con un organismo diferente a la cándida.
    - Niños con historia de hipersensibilidad o reacción vasomotora severa a cualquier equinocándida o fluconazol.
    - Niños con enfermedad hepática o renal.
    E.5 End points
    E.5.1Primary end point(s)
    PK/PD integration of pharmacokinetics and pharmacodynamics
    PK/PD integración de farmacocinética y farmacodinámica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to reach the AUC breakpoint ant the ratio of AUC/MIC90s in the two treated groups
    Tiempo para alcanzar el punto de corte AUC y el índice AUC/MIC90s en los dos grupos de tratamiento.
    E.5.2Secondary end point(s)
    Definition of efficacy evaluation criteria (primary and secondary) measurement techniques
    Definición dlas medidas técnicas de los criterios de evaluación de la eficacia (primaria y secundaria)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The procedures or evaluations will be performed on the days of PK study
    Los procedimientos o evaluaciones se realizarán en los días del estudio PK.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days45
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial days45
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 30
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 30
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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