Community-acquired PneumoniaPhase 3ALBUCAPNCT04071041
Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia.
A Phase 3 study testing Albumin Human in people with Community-acquired Pneumonia and Hypoalbuminemia, run by Jordi Carratala at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Hypoalbuminemia
- What is being tested?
- Albumin Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesSpain
- Study dates
- 31 Oct 2019to 31 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
SCIAS-Hospital de Barcelona
Barcelona, 08034
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, 08810
About this study
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.
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia, Hypoalbuminemia
- Being tested
- Albumin Human
- Keywords
- Community-acquired Pneumonia, Albumin, Inflammation
- Medical subject headings
- Community-Acquired Pneumonia, Hypoalbuminemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin HumanDrug
Also called Albutein
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 5±1 of hospitalization
Secondary outcomes (8)
Time to clinical stability (days) measured from hospital admission
The time (days) to clinical stability, measured from hospital admission
Measured: Up to 30 ±5 days after discharge
Duration of intravenous and total antibiotic treatment (days).
The duration of intravenous and total duration of antibiotic treatment (measured in days)
Measured: Up to 30 ±5 days after discharge
Length of hospital stay (days).
The total length of hospital stay (measured in days)
Measured: Up to hospital discharge - a median of 10 days
Proportion of patients with intensive care unit (ICU) admission.
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
Measured: Up to hospital discharge - a median of 10 days
The rate of nosocomial infection during hospitalization
The proportion of patients with nosocomial infection during hospitalization will be registered, the type of nosocomial infection will be described
Measured: Up to hospital discharge - a median of 10 days
Proportion of adverse events.
Any adverse event, its severity and its possible relationship to the study drug will be assessed
Measured: Up to 30 ±5 days after discharge
The number of patients with hospital readmission within 30 days of discharge
We will document hospital readmission within 30 days of discharge
Measured: Up to 30 ±5 days after discharge
All-cause mortality
5-day mortality, 30-day mortality and mortality within 30 days of hospital discharge.
Measured: Up to 30 ±5 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 Oct 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordi Carratala
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Sponsor-investigator, Jordi Carratala, Hospital Universitari de Bellvitge
- Investigators
- Alexander Rombauts, Principal investigator, Institut d'Investigació Biomèdica de BellvitgeJordi Carratalà, Study director, Hospital Universtari de Bellvitge, Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071041
- Sponsor's protocol ID
- HUB-INF-ALBUCAP-402
- Other IDs
- 2018-003117-18, PI17/01332, 2018
- Acronym
- ALBUCAP
- Status last verified
- Jan 2023
- First submitted
- 31 Jul 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32819439
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04071041
- Acronym / sponsor ID
- ALBUCAP / HUB-INF-ALBUCAP-402
- Conditions
- Community-acquired Pneumonia, Hypoalbuminemia
- Keywords
- Community-acquired Pneumonia, Albumin, Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Jordi CarratalaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care plus albumin | Experimental | Drug: Albumin HumanPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin HumanAlso: AlbuteinAdministration 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. | Drug | Standard care plus albumin |
Primary outcome
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
8 secondary outcomes
Time to clinical stability (days) measured from hospital admission
Time frame: Up to 30 ±5 days after discharge
Duration of intravenous and total antibiotic treatment (days).
Time frame: Up to 30 ±5 days after discharge
Length of hospital stay (days).
Time frame: Up to hospital discharge - a median of 10 days
Proportion of patients with intensive care unit (ICU) admission.
Time frame: Up to hospital discharge - a median of 10 days
The rate of nosocomial infection during hospitalization
Time frame: Up to hospital discharge - a median of 10 days
Proportion of adverse events.
Time frame: Up to 30 ±5 days after discharge
The number of patients with hospital readmission within 30 days of discharge
Time frame: Up to 30 ±5 days after discharge
All-cause mortality
Time frame: Up to 30 ±5 days after discharge
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 32819439Rombauts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Rombauts principal investigator
Institut d'Investigació Biomèdica de Bellvitge
Jordi Carratalà study director
Hospital Universtari de Bellvitge, Universitat de Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin Human in people with Community-acquired Pneumonia and Hypoalbuminemia, run by Jordi Carratala at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinical stable patients at day 5, measured from hospital admission. (time frame: Day 5±1 of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.