Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.

NCT04071041 | Terminated Phase 3 DMC

• 3 other identifiers: HUB-INF-ALBUCAP-4022018-003117-18PI17/01332
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain. This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.

Conditions

Community-acquired Pneumonia; Hypoalbuminemia

Keywords

Community-acquired Pneumonia; Albumin; Inflammation

Outcome Measures

Primary Outcomes (1)

• The proportion of clinical stable patients at day 5, measured from hospital admission.

  Clinical stability will be defined as achieving normal oral intake, normal mental status (or usual level of functioning) and stable vital signs for at least 24 h, as previously described by Halm et al 1998

  Day 5±1 of hospitalization

Secondary Outcomes (8)

• Time to clinical stability (days) measured from hospital admission

  Up to 30 ±5 days after discharge

• Duration of intravenous and total antibiotic treatment (days).

  Up to 30 ±5 days after discharge

• Length of hospital stay (days).

  Up to hospital discharge - a median of 10 days

• Proportion of patients with intensive care unit (ICU) admission.

  Up to hospital discharge - a median of 10 days

• The rate of nosocomial infection during hospitalization

  Up to hospital discharge - a median of 10 days

Study Arms (2)

Standard care plus albumin

EXPERIMENTAL

Patients will receive human albumin 20%, 20g in 100ml (Albutein Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08015 Barcelona, Spain) intravenously every 12 hours for 4 days or until death, discharge or clinical stability if occurring before. Patients will receive empirical antibiotic therapy according to guidelines as soon as CAP is confirmed. All microbiological assessments and additional treatment (e.g. oxygen, bronchodilators, corticosteroids, analgesic drugs, vasoactive agents, fluid resuscitation, and mechanical ventilation) will be at the discretion of the treating physicians (not the study investigators). The time of discharge and duration of antibiotics will not be determined by the study investigators, but by the treating physician team.

Drug: Albumin Human

Standard care alone

NO INTERVENTION

Patients will receive empirical antibiotic therapy according to guidelines as soon as CAP is confirmed. All microbiological assessments and additional treatment (e.g. oxygen, bronchodilators, corticosteroids, analgesic drugs, vasoactive agents, fluid resuscitation, and mechanical ventilation) will be at the discretion of the treating physicians (not the study investigators). The time of discharge and duration of antibiotics will not be determined by the study investigators, but by the treating physician team.

Interventions

Albumin Human DRUG

Administration of albumin 20%, 20g in 100ml (Albutein Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08015 Barcelona, Spain) intravenously every 12 hours for 4 days or until death, discharge or clinical stability if occurring before.

Also known as: Albutein

Standard care plus albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of CAP (Chest radiography consistent with CAP AND the presence of ≥2 following prespecified clinical criteria: Fever or hypothermia; Cough; Purulent sputum; High white blood cell count; Dyspnea; Pleuritic chest pain; Signs consistent with pneumonia on chest auscultation)
• Serum albumin concentration ≤ 30 g/L at presentation

You may not qualify if:

• Pregnancy or lactation
• Immunosuppression (e.g. chemotherapy or radiotherapy within 90 days, immunosuppressive drugs, corticosteroids at a minimum dose of 15mg/day of prednisone within 2 weeks of enrolment, HIV with a CD4 count below 200, solid organ transplant recipients, hematopoietic cell transplant recipients).
• Severe clinical status with expected survival of less than 24h.
• Congestive heart failure (New York Heart Association classes 3 or 4)
• Any contraindication for albumin administration such as hypersensitivity to albumin.
• Clinical conditions in which there is another indication for albumin administration (e.g. hepatic cirrhosis with ascites, malabsorption syndrome and nephrotic syndrome).
• Absence or impossibility of obtaining informed consent from the patient/next of kin.
• Patient already included in another clinical trial testing a treatment method.

Sponsors & Collaborators

• Jordi Carratala: lead
• Instituto de Salud Carlos III: collaborator
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (3)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Residència Sant Camil

Sant Pere de Ribes, Barcelona, 08810, Spain

Location

SCIAS-Hospital de Barcelona

Barcelona, 08034, Spain

Location

Related Publications (1)

• Rombauts A, Abelenda-Alonso G, Simonetti AF, Verdejo G, Meije Y, Ortega L, Clemente M, Niubo J, Ruiz Y, Gudiol C, Tebe C, Videla S, Carratala J. Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial-a trial protocol. Trials. 2020 Aug 20;21(1):727. doi: 10.1186/s13063-020-04627-1.

  PMID: 32819439 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia; Hypoalbuminemia; Inflammation

Interventions

Serum Albumin, Human; Albumins

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum Albumin; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Alexander Rombauts

  Institut d'Investigació Biomèdica de Bellvitge

  PRINCIPAL INVESTIGATOR

• Jordi Carratalà

  Hospital Universtari de Bellvitge, Universitat de Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Model Details: A superiority, non-blinded, multicentre, randomized, interventional controlled clinical trial. Patients will be randomly assigned (1:1) to receive standard of care plus albumin (20g in 100ml) every 12 hours for 4 days or standard of care alone.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 28, 2019
• Study Start: October 31, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)