Clinical Trials Register

Summary
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

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

2018-003117-18

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

HUB-INF-ALBUCAP-402

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	Dr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fondos de Investigación Sanitarioas (FIS) Instituto Carlos III
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	Dr. Alexander Rombauts Servicio de Enfermedades Infecciosas. Hospital Universitario de Bellvitge
B.5.2	Functional name of contact point	Dr. Alexander Rombauts
B.5.3	Address:
B.5.3.1	Street Address	Calle Feixa Llarga, s/n
B.5.3.2	Town/ city	L'Hospitalet de Llobregat (Barcelona)
B.5.3.3	Post code	08907
B.5.3.4	Country	Spain
B.5.4	Telephone number	34932607625
B.5.5	Fax number	34932607637
B.5.6	E-mail	arombauts@bellvitgehospital.cat

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	Albutein 20% solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	Instituto Grifols, 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	Albúmina
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALBUMINA
D.3.9.1	CAS number	9006-53-5
D.3.9.2	Current sponsor code	ALBUMINA
D.3.9.3	Other descriptive name	HUMAN SERUM ALBUMIN
D.3.9.4	EV Substance Code	SUB20344
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Community-acquired pneumonia (CAP)

Neumonía adquirida en la comunidad (NAC)

E.1.1.1

Medical condition in easily understood language

Hypoalbuminemic patients hospitalized with community-acquired pneumonia (CAP)

Pacientes hipoalbuminémicos hospitalizados con Neumonía asquirida en la comunidad (NAC)

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10035664
E.1.2	Term	Pneumonia
E.1.2	System Organ Class	10021881 - Infections and infestations

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 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.2.2

Secondary objectives of the trial

CLINICAL ASSESSMENT CRITERIA:
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
SECURITY ASSESSMENT CRITERIA:
To evaluate safety (incidence of adverse events according to seriousness and causality by treatment) of experimental vs. control treatment.

CLINICOS:
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
SEGURIDAD
1) Evaluar seguridad (incidencia acontecimientos adversos según gravedad y relación con el tto) del tto experimental comparada con ttto control

E.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(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.5.2

Secondary end point(s)

CLINICAL ASSESSMENT CRITERIA:
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)
CAP-RELATED COMORBIDITY:
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
MORTALITY:
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
SECURITY ASSESSMENT CRITERIA:
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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

ESTANDAR DE CUIDADO

STANDARD OF CARE

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

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.8.9.1

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:

144

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

216

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

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 2019-04-12.

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

Yes

F.3.3.6.1

Details 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.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

360

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-06

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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