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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43691   clinical trials with a EudraCT protocol, of which   7246   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2018-003117-18
    Sponsor's Protocol Code Number:HUB-INF-ALBUCAP-402
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003117-18
    A.3Full title of the trial
    A phase III randomized, controlled, open label multicenter clinical trial, with two parallel groups, to evaluate the efficacy of albumin administration in patients hospitalized with community-acquired pneumonia (ALBUCAP)
    Ensayo clínico de fase III, con asignación aleatoria, controlado, abierto y multicéntrico, con dos grupos paralelos, para evaluar la eficacia de la administración de albúmina en pacientes hospitalizados con neumonía adquirida en la comunidad (ALBUCAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the efficacy of albumin administration in patients hospitalized with community-acquired pneumonia (ALBUCAP)
    Evaluar la eficacia de la administración de albúmina en pacientes hospitalizados con neumonía adquirida en la comunidad (ALBUCAP)
    A.4.1Sponsor's protocol code numberHUB-INF-ALBUCAP-402
    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 SponsorDr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge
    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 supportFondos de Investigación Sanitarioas (FIS) Instituto Carlos III
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Alexander Rombauts Servicio de Enfermedades Infecciosas. Hospital Universitario de Bellvitge
    B.5.2Functional name of contact pointDr. Alexander Rombauts
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.4Telephone number34932607625
    B.5.5Fax number34932607637
    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. name Albutein 20% solución para perfusión
    D. of the Marketing Authorisation holderInstituto Grifols, S.A.
    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 nameAlbúmina
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALBUMINA
    D.3.9.1CAS number 9006-53-5
    D.3.9.2Current sponsor codeALBUMINA
    D.3.9.3Other descriptive nameHUMAN SERUM ALBUMIN
    D.3.9.4EV Substance CodeSUB20344
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Community-acquired pneumonia (CAP)
    Neumonía adquirida en la comunidad (NAC)
    E.1.1.1Medical condition in easily understood language
    Hypoalbuminemic patients hospitalized with community-acquired pneumonia (CAP)
    Pacientes hipoalbuminémicos hospitalizados con Neumonía asquirida en la comunidad (NAC)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the short-term efficacy (on day 5 from the beginning of the study treatment, 'end of treatment', EoT) of intravenous albumin in adult, hypoalbuminemic patients, hospitalized with CAP, evaluated as number of patients with clinical stability
    Estudiar la eficacia a corto plazo (en el día 5 de iniciar el tratamiento a estudio, ‘end of treatment’, EoT) de la albúmina intravenosa en pacientes adultos, hipoalbuminémicos, hospitalizados con NAC, evaluado como número de pacientes con estabilidad clínica
    E.2.2Secondary objectives of the trial
    1) To study the short-term efficacy (on day 5 from starting the study treatment, 'end of treatment', EoT) of intravenous albumin in adult, hypoalbuminemic patients, hospitalized with CAP, evaluated as days to reach clinical stability
    2) To study the long-term efficacy (30 days after hospital discharge, test of cure, ToC) of intravenous albumin in adult, hypoalbuminemic patients, hospitalized with CAP, evaluated as days to reach clinical stability
    3) To assess the duration of antibiotic treatment (days, intravenous and total)
    4) To assess the duration of hospital stay (days)
    5) To assess the incidence of CAP-related comorbidities up to 30 days after discharge
    6) To assess the all-cause mortality incidence up to 30 days after discharge
    To evaluate safety (incidence of adverse events according to seriousness and causality by treatment) of experimental vs. control treatment.
    1)Estudiar eficacia corto plazo (el día 5 de iniciar tto estudio,end of treatment,EoT) de albúmina intravenosa,evaluado como tiempo (días) hasta estabilidad clínica,intravenosa en pac adultos,hipoalbuminémicos,hospitalizados con NAC,evaluado como “días hasta” hasta estabilidad clínica
    2)Estudiar eficacia largo plazo (a los 30 días del alta hospitalaria,test of cure,ToC) de albúmina intravenosa en pac adultos, hipoalbuminémicos, hospitalizados con NAC, evaluado como “días hasta” hasta estabilidad clínica
    3)Cuantificar duración (días) tto antibiótico (intravenoso y total)
    4)Cuantificar duración (días) estancia hospitalaria
    5)Evaluar incidencia comorbilidades relacionadas con NAC hasta los 30 días alta hospital
    6)Evaluar incidencia mortalidad por cualquier causa hasta los 30 días alta hospital
    1) Evaluar seguridad (incidencia acontecimientos adversos según gravedad y relación con el tto) del tto experimental comparada con ttto control
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adult patients (18 years or older), of both genders, hospitalized for CAP
    2) Patients with a hypoalbuminemia (serum albumin ≤30 g/L)
    3)Subjects, their legal representative or closest familiar (in case of incapacity of the subject due to the seriousness of the clinical situation: patients hospitalized in ICU, delirium) otorgates the informed consent.
    1) Pacientes adultos (18 años o más), de ambos sexos, hospitalizados con diagnóstico de NAC
    2) Pacientes con hipoalbuminemia (albúmina sérica ≤30 g/L)
    3) El sujeto, su representante legal o familiar más cercano (en caso de incapacidad del sujeto por gravedad de la situación clínica) otorgan el consentimiento informado
    E.4Principal exclusion criteria
    1) Pregnancy and/or breastfeeding. If a subject is a female of childbearing potential, she must have a negative result on an approved urine pregnancy test at the time of screening.
    2) Severe immunosuppressed patients (e.g. chemotherapy or radiotherapy in the previous 90 days, receiving immunosuppressants, chronic use of corticosteroids at a minimum dose of 15 mg/day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplantation, HIV patients with CD4 less than 200)
    3) Imminent death
    4) Congestive heart failure (NYHA class 3 or 4)
    5) Known adverse reactions to albumin or some of its excipients
    6) Conditions in which there is another indication for the administration of albumin (e.g. liver cirrhosis with ascites, malabsorption syndrome, nephrotic syndrome)
    7) Participation in another clinical trial in the three previous months.
    1) Embarazo y/o lactancia. En mujeres en edad fértil se descartará la posibilidad de gestación mediante un test de embarazo.
    2) Inmunodeprimidos graves (ej. quimioterapia o radioterapia en los 90 días previos, uso de fármacos inmunosupresores, uso crónico de corticoides a la dosis mínima de 15 mg/día en las últimas dos semanas, trasplante de progenitores hematopoyéticos, trasplante de órgano sólido, pacientes HIV con CD4 inferiores a 200)
    3) Muerte inminente
    4) Insuficiencia cardíaca congestiva (clase 3 o 4 de la NYHA)
    5) Reacciones adversas conocidas a la albúmina o algunos de sus excipientes
    6) Condiciones en las que hay otra indicación para la administración de albúmina (por ejemplo, cirrosis hepática con ascitis, síndrome de malabsorción, síndrome nefrótico)
    7) Participación en otro ensayo clínico de tratamiento en los tres meses previos.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients achieving clinical stability on day 5 (EoT)
    Número de pacientes que alcanzan la estabilidad clínica en el día 5 de estudio (EoT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    On day 5 from starting study treatment, 'end of treatment', EoT.
    En el día 5 de iniciar el tratamiento a estudio, ‘end of treatment’, EoT
    E.5.2Secondary end point(s)
    1) Time (days) to reach clinical stability on day 5; 2) Long-term efficacy: time to reach clinical stability (up to 30 days after discharge); 3) Duration of antibiotic treatment (days) ; 4)Length of hospital stay (days)
    1) Patients admitted in ICU; 2) Patients requiring mechanical ventilation; 3) Patients admitted in ICU and requiring mechanical ventilation; 4) Patients with a diagnosis of nosocomial infection; 5) Patients re-admitted in the first 30 days after discharge
    1) Patients deceased on day 5 from the beginning of the study (early mortality).
    2) Patients deceased on day 30 from the beginning of the study (30-day mortality); 3) Patients deceased, for CAP-related cause, up to 30 days from hospital discharge; 4) Patients deceased for any cause up to 30 days from hospital discharge
    1) Adverse events incidence according to seriousness and causality by treatment
    CLINICOS:1)Tiempo (días) hasta alcanzar estabilidad clínica en el dia 5; 2)Eficacia largo plazo,tiempo (días) hasta alcanzar estabilidad clínica(hasta 30 tras alta hospital); 3)Duración del tto antibiótico días); 4)Días de ingreso. COMORBILIDAD RELACIONADOS CON NAC: 1)Num. Pac ingresan UCI 2)Pac necesitan ventilación mecánica 3)Pac ingresan UCI y ventilación mecánica 4)Pac Dx infección nosocomial5)Pac reingreso hospital antes 30 d desde alta hospital MORTALIDAD:1)Pac fallecidos a 5 d iniciado tto estudio (mortalidad precoz).2)Pac fallecidos a 30 tto estudio (mortalidad a 30 d) 3)Pac fallecidos,relacionados NAC, hasta 30 d desde alta hospital4)Pac fallecidos cualquier causa hasta 30 d desde alta hospital CRITERIOS DE VALORACIÓN DE LA SEGURIDAD:1)Incidencia acontecimientos adversos según gravedad y relación tto
    E.5.2.1Timepoint(s) of evaluation of this end point
    On day 30 from hospital discharge, 'test of cure', ToC.
    A los 30 días del alta hospitalaria, ‘test of cure’, ToC
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    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 concerned3
    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
    The study will end with the completion of the follow-up monitoring and data collection (last patient-last visit).
    El estudio finalizará cuando finalice la evaluación (visita a los 30 días desde el alta hospitalaria del último paciente incluido en el estudio (“Last Patient-Last Visit”).
    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 months3
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 216
    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 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 2019-04-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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. of subjects incapable of giving consent
    In patients unable to provide consent due to medical condition (patients hospitalized in the ICU, intubation, delirium), surrogate consent can be obtained from the patient’s next of kin.
    En caso de que el paciente no pueda otorgar su consentimiento informado debido a su estado médico (ingreso en la UCI, intubación, síndrome confusional agudo), se podrá obtener el consentimiento de un familiar cercano.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    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)
    Patients at the end of trial treatment will continue treatment according to usual clinical practice.
    Los pacientes al finalizar el tratamiento del ensayo continuaran tratamiento según práctica clínica 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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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