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    Summary
    EudraCT Number:2022-003106-72
    Sponsor's Protocol Code Number:IIBSP-SUR-2022-61
    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:2023-02-24
    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 number2022-003106-72
    A.3Full title of the trial
    Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) amenable to treatment with exogenous surfactant identified early by pulmonary ultrasonography
    Ensayo clínico aleatorizado simple ciego en prematuros con Síndrome de Distrés Respiratorio (SDR) tributarios de tratamiento con surfactante exógeno identificados precozmente mediante ultrasonografía pulmonar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in premature infants with Respiratory Distress Syndrome (RDS) amenable to treatment with exogenous surfactant identified early by pulmonary ultrasonography
    Estudio en prematuros con Síndrome de Distrés Respiratorio (SDR) que requieren tratamiento con surfactante exógeno identificados precozmente mediante ultrasonografía pulmonar
    A.4.1Sponsor's protocol code numberIIBSP-SUR-2022-61
    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 SponsorInstitut de Recerca H. de la Santa Creu i Sant Pau
    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 supportInstitut de Recerca H. de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537634
    B.5.6E-mailuicec@santpau.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 Curosurf
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI ESPANA
    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 Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCUROSURF
    D.3.9.1CAS number 129069-19-8
    D.3.9.3Other descriptive namePORCINE LUNG SURFACTANT
    D.3.9.4EV Substance CodeSUB192678
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Respiratory Distress Syndrome
    Síndrome de Distrés Respiratorio
    E.1.1.1Medical condition in easily understood language
    Respiratory Distress Syndrome
    Síndrome de Distrés Respiratorio
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 compare the efficacy of two schemes of exogenous pulmonary surfactant administration, in RNP with RDS (One of them indicated under lung ultrasound criteria versus the other following the recommendations of the current guidelines), in terms of reducing the number of intubations in the first 72 hours of life.
    - Comparar la eficacia de dos esquemas de administración de surfactante pulmonar exógeno, en RNP con SDR (Uno de ellos indicado bajo criterios de ecografía pulmonar versus el otro siguiendo las recomendaciones de las guías actuales), en términos de disminución del número de intubaciones en las primeras 72 horas de vida.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of the early administration of exogenous surfactant compared to the usual regimen in terms of reducing the need for oxygen therapy by at least 20%.
    - Compare between both groups, the number of RNP that require a second dose of surfactant.
    - To compare the efficacy in terms of reduction in the time (days) of necessary respiratory support, in the experimental group versus the control group.
    - Compare the incidence of development of bronchopulmonary dysplasia (BPD) in the experimental group versus the control group.
    - Compare the incidence of intraventricular hemorrhage between both groups.
    - Compare the LUS score at 24 hours, 7 days, 14 days and 28 days of both study groups.
    - Compare the morbidity and mortality in the 2 groups.
    - Valorar la eficacia de la administración precoz de surfactante exógeno en comparación con el esquema habitual en términos de disminución de las necesidades de oxigenoterapia de al menos un 20%.
    - Comparar entre ambos grupos, el número de RNP que precisen de una segunda dosis de surfactante.
    - Comparar la eficacia en términos de disminución del tiempo (días) de soporte respiratorio necesario, en el grupo experimental versus el grupo control.
    - Comparar la incidencia del desarrollo de Displasia broncopulmonar (DBP) en el grupo experimental versus el grupo control.
    - Comparar la incidencia de hemorragia intraventricular entre ambos grupos.
    - Comparar el score LUS a las 24 horas, 7 días, 14 días y 28 días de ambos grupos en estudio.
    - Comparar la morbimortalidad en los 2 grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study population will be made up of premature infants under 32 weeks and/or ≤1500gr. Subjects will be assigned according to simple randomization by letter and there will be single blind masking.
    La población en estudio estará constituida por prematuros menores de 32 semanas y/o ≤1500gr. Los sujetos serán asignados de acuerdo a aleatorización simple por carta y habrá enmascaramiento simple ciego.
    E.4Principal exclusion criteria
    Non-acceptance of informed parental consent.
    Patients presenting any of the following conditions:
    - Chromosomal abnormalities or complex congenital malformations.
    - Congenital lung diseases.
    - Severe sepsis or septic shock.
    - Meconium aspiration syndrome.
    - Administration of surfactant in the delivery room.
    No aceptación del consentimiento informado de los padres.
    Pacientes que presenten alguna de las siguientes condiciones:
    - Anomalías cromosómicas o malformaciones congénitas complejas.
    - Enfermedades pulmonares congénitas.
    - Sepsis grave o shock séptico.
    - Síndrome de aspiración de meconio.
    - Administración de surfactante en la sala de partos.
    E.5 End points
    E.5.1Primary end point(s)
    Intubation rate in the next 72 hours of life.
    Tasa de intubación en las próximas 72 horas de vida.
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours
    72 horas
    E.5.2Secondary end point(s)
    - Percentage decrease in oxygen therapy needs after surfactant administration.
    - Rate of administration of a second dose in both groups.
    - Rate of reduction in the need for respiratory support used in the experimental group versus the control group.
    - Percentage of development of bronchopulmonary dysplasia (DBP) in both groups.
    - Percentage of intraventricular hemorrhage between both groups, derived from the respiratory intervention.
    - LUS reduction rate at 24 hours, 7 days, 14 days and 28 days in both study groups.
    - Rate of morbidity and mortality in the 2 RNP groups based on the surfactant treatment criteria used.
    - Porcentaje de disminución de las necesidades de oxigenoterapia tras la administración de surfactante.
    - Tasa de administración de una segunda dosis en ambos grupos.
    - Tasa de reducción de la necesidad de soporte respiratorio utilizado en el grupo experimental versus el grupo control.
    - Porcentaje de desarrollo de Displasia broncopulmonar (DBP) en ambos grupos.
    - Porcentaje de hemorragia intraventricular entre ambos grupos, derivadas de la intervención a nivel respiratorio.
    - Tasa de reducción del LUS a las 24 horas, 7 días, 14 días y 28 días de ambos grupos en estudio.
    - Tasa de morbimortalidad en los 2 grupos de RNP en función del criterio de tratamiento con surfactante utilizado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours, 7 days, 14 days and 28 days.
    24 horas, 7 días, 14 días y 28 días.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Ultima visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) 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) 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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm newborns
    Recién nacidos pretérmino
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Expected normal treatment of the condition
    Tratamiento habitual
    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 Decision2023-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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