To evaluate the efficacy of albumin administration in patients hospitalized with community-acquired pneumonia (ALBUCAP)

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003117-18-ES

Enrollment

360

Registered

2019-04-12

Start date

2019-07-10

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired pneumonia (CAP) MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Albutein 20% solución para perfusión Product Name: Albúmina Pharmaceutical Form: Solution for infusion INN or Proposed INN: ALBUMINA CAS Number: 9006-53-5 Current Sponsor code: ALBUMINA Ot

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: 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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: 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.;Primary end point(s): Number of patients achieving clinical stability on day 5 (EoT);Timepoint(s) of evaluation of this end point: On day 5 from starting study treatment, 'end of treatment', EoT.	—

Measure

Time frame

Main Objective: 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;Secondary Objective: 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.;Primary end point(s): Number of patients achieving clinical stability on day 5 (EoT);Timepoint(s) of evaluation of this end point: On day 5 from starting study treatment, 'end of treatment', EoT.

—

Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: On day 30 from hospital discharge, 'test of cure', ToC.	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: On day 30 from hospital discharge, 'test of cure', ToC.

—

Countries

Spain

Contacts

Public ContactDr. Alexander Rombauts

Dr. Alexander Rombauts Servicio de Enfermedades Infecciosas. Hospital Universitario de Bellvitge

arombauts@bellvitgehospital.cat34932607625

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026