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

• ClinicalTrials.gov Identifier: NCT04071041
• Recruitment Status: Recruiting
• First Posted: August 28, 2019
• Last Update Posted: March 5, 2020
• Sponsor: Jordi Carratala
• Collaborators: Instituto de Salud Carlos III; Institut d'Investigació Biomèdica de Bellvitge
• Information provided by (Responsible Party): Jordi Carratala, Hospital Universitari de Bellvitge

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Community-acquired Pneumonia; Hypoalbuminemia	Drug: Albumin Human	Phase 3

Detailed Description:

This project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. The estimated sample size is of 360 patients, who will be recruited from three Spanish hospitals. Hypoalbuminemic (≤30g/L) adult patients with CAP will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone.

The primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat.

The secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.
• Actual Study Start Date: October 31, 2019
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standard care plus albumin; 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; 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.; Other Name: Albutein
No Intervention: Standard care alone; 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.

Outcome Measures

Primary Outcome Measures :

1. The proportion of clinical stable patients at day 5, measured from hospital admission. [ Time Frame: Day 5±1 of hospitalization ]
   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

Secondary Outcome Measures :

1. Time to clinical stability (days) measured from hospital admission [ Time Frame: Up to 30 ±5 days after discharge ]
   The time (days) to clinical stability, measured from hospital admission
2. Duration of intravenous and total antibiotic treatment (days). [ Time Frame: Up to 30 ±5 days after discharge ]
   The duration of intravenous and total duration of antibiotic treatment (measured in days)
3. Length of hospital stay (days). [ Time Frame: Up to hospital discharge - a median of 10 days ]
   The total length of hospital stay (measured in days)
4. Proportion of patients with intensive care unit (ICU) admission. [ Time Frame: Up to hospital discharge - a median of 10 days ]
   The number of patients admitted to intensive care. For those admitted to ICU we will record: time to discharge from ICU; duration of vasopressor treatment; duration of mechanical ventilation
5. The rate of nosocomial infection during hospitalization [ Time Frame: Up to hospital discharge - a median of 10 days ]
   The proportion of patients with nosocomial infection during hospitalization will be registered, the type of nosocomial infection will be described
6. Proportion of adverse events. [ Time Frame: Up to 30 ±5 days after discharge ]
   Any adverse event, its severity and its possible relationship to the study drug will be assessed
7. The number of patients with hospital readmission within 30 days of discharge [ Time Frame: Up to 30 ±5 days after discharge ]
   We will document hospital readmission within 30 days of discharge
8. All-cause mortality [ Time Frame: Up to 30 ±5 days after discharge ]
   5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Contacts

Contact: Alexander Rombauts; +34 932607625; arombauts@bellvitgehospital.cat

Locations

Spain

Hospital Universitari de Bellvitge; Recruiting

Hospitalet de Llobregat, Barcelona, Spain, 08907

Contact: Alexander Rombauts, MD 660434413 ext 0034 arombauts@bellvitgehospital.cat

Hospital Residència Sant Camil; Recruiting

Sant Pere de Ribes, Barcelona, Spain, 08810

Contact: Antonella F Simonetti, PhD antonella.f.simonetti@gmail.com

SCIAS-Hospital de Barcelona; Recruiting

Barcelona, Spain, 08034

Contact: Yolanda Meije, PhD yolandameije@gmail.com

Sponsors and Collaborators

Jordi Carratala

Instituto de Salud Carlos III

Institut d'Investigació Biomèdica de Bellvitge

Investigators

• Principal Investigator: Alexander Rombauts; Institut d'Investigació Biomèdica de Bellvitge
• Study Director: Jordi Carratalà; Hospital Universtari de Bellvitge, Universitat de Barcelona

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rombauts A, Abelenda-Alonso G, Simonetti AF, Verdejo G, Meije Y, Ortega L, Clemente M, Niubó J, Ruiz Y, Gudiol C, Tebé C, Videla S, Carratalà 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.

• Responsible Party: Jordi Carratala, Sponsor, Hospital Universitari de Bellvitge
• ClinicalTrials.gov Identifier: NCT04071041
• Other Study ID Numbers: HUB-INF-ALBUCAP-402; 2018-003117-18 ( EudraCT Number ); PI17/01332 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
• First Posted: August 28, 2019
• Last Update Posted: March 5, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordi Carratala, Hospital Universitari de Bellvitge:

Community-acquired Pneumonia; Albumin; Inflammation

Additional relevant MeSH terms:

Pneumonia; Hypoalbuminemia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases