Age Associated Immune DeficiencyNCT04062799
Immunophenotype of Risk in Older Patients Admitted for Pneumonia
An observational study of Age Associated Immune Deficiency and Elderly Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age Associated Immune Deficiency, Elderly Infection, Pneumonia
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2019to Jan 2024
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥ 65 years old admitted for pneumonia in the "Hospital de la Santa Creu i Sant Pau in Barcelona". Pneumonia will be defined in the presence of a new infiltrate in the chest radiograph along with one or more compatible signs or symptoms: fever, chills, cough, expectoration or malaise.
Who may be able to join
- patients ≥ 65 years old admitted for pneumonia in the "Hospital de la Santa Creu i Sant Pau in Barcelona".
Who cannot join
- patients from another acute care hospital
- patients with HIV infection
- neutropenic patients (neutrophil count <1000 / mm3)
- transplant patients
- patients in end-of-life situation
- not having written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of an Immunophenotype of Risk of Poor Prognosis in Elderly Patients Who Have Been Admitted for Pneumonia
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated.
If the hypothesis is confirmed, helpful immunological markers will be identified. This will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. Otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.
Read the detailed description
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated.
Methodology: Prospective observational study. It will include 149 patients ≥ 65 years admitted for pneumonia. After 30-45 days of pneumonia diagnosis, a complete clinical, functional, nutritional and immunological assessment will be carried out. FRI will be defined as a positive cytomegalovirus serology together with at least one of the following: CD4 / CD8 <1, CD8 T cells> 600 / μl or negative CD28 T cells> 300 / μl15. Mortality and re-admissions at 12 and 18 months will be evaluated.
If the hypothesis is confirmed, helpful immunological markers will be identified. This will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. Otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.
- Conditions
- Age Associated Immune Deficiency, Elderly Infection, Pneumonia, Nutrition Disorders in Old Age, Frail Elderly Syndrome, Sarcopenia
- Being tested
- no intervention
- Medical subject headings
- Pneumonia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It is an observationa study. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of the immune risk phenotype (IRP)
To assess whether the presence of the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to higher mortality after 18 months of pneumonia.
Measured: 18 months
Secondary outcomes (4)
Number of readmissions
To assess number of readmissions at 18 months.
Measured: 18 months
Immunological markers other than IRP
To evaluate if immunological markers other than IRP predispose to higher mortality or readmission rates
Measured: 18 months
Immunological profile
To describe the basic immunological profile of the elderly who have been admitted due to pneumonia and its evolution after the acute phase.
Measured: 18 months
Immunological alterations
To study if there is an association between IRP and clinical, functional, nutritional, comorbidity risk factors or frailty/sarcopenia.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 May 2019
- Primary completionJul 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Associated Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
- Investigators
- Olga H Torres, PhD MD, Principal investigator, Hospital de Sant Pau. Universitat Autònoma de Barcelona. Institut de Recerca Sant Pau.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062799
- Sponsor's protocol ID
- IIBSP-NEU-2018-118
- Status last verified
- Nov 2021
- First submitted
- 6 May 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of an Immunophenotype of Risk of Poor Prognosis in Elderly Patients Who Have Been Admitted for Pneumonia
- ClinicalTrials.gov ID
- NCT04062799
- Acronym / sponsor ID
- IIBSP-NEU-2018-118
- Conditions
- Age Associated Immune Deficiency, Elderly Infection, Pneumonia, Nutrition Disorders in Old Age, Frail Elderly Syndrome, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- 9 May 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 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.
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated.
If the hypothesis is confirmed, helpful immunological markers will be identified. This will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. Otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.
Detailed description
The objective is to evaluate if the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. In addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated.
Methodology: Prospective observational study. It will include 149 patients ≥ 65 years admitted for pneumonia. After 30-45 days of pneumonia diagnosis, a complete clinical, functional, nutritional and immunological assessment will be carried out. FRI will be defined as a positive cytomegalovirus serology together with at least one of the following: CD4 / CD8 <1, CD8 T cells> 600 / μl or negative CD28 T cells> 300 / μl15. Mortality and re-admissions at 12 and 18 months will be evaluated.
If the hypothesis is confirmed, helpful immunological markers will be identified. This will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. Otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: no intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥ 65 years old admitted for pneumonia in the "Hospital de la Santa Creu i Sant Pau in Barcelona". Pneumonia will be defined in the presence of a new infiltrate in the chest radiograph along with one or more compatible signs or symptoms: fever, chills, cough, expectoration or malaise.
Key inclusion criteria (1 listed)
- patients ≥ 65 years old admitted for pneumonia in the "Hospital de la Santa Creu i Sant Pau in Barcelona".
Key exclusion criteria (6 listed)
- patients from another acute care hospital
- patients with HIV infection
- neutropenic patients (neutrophil count <1000 / mm3)
- transplant patients
- patients in end-of-life situation
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 |
|---|---|---|
| no interventionIt is an observationa study. There is no intervention. | Other | Study cohort |
Primary outcome
Presence of the immune risk phenotype (IRP)
Time frame: 18 months
To assess whether the presence of the immune risk phenotype (IRP) in patients who have been admitted for pneumonia predisposes to higher mortality after 18 months of pneumonia.
4 secondary outcomes
Number of readmissions
Time frame: 18 months
Immunological markers other than IRP
Time frame: 18 months
Immunological profile
Time frame: 18 months
Immunological alterations
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
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.
Olga H Torres, PhD MD principal investigator
Hospital de Sant Pau. Universitat Autònoma de Barcelona. Institut de Recerca Sant Pau.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Associated Immune Deficiency and Elderly Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
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?
Presence of the immune risk phenotype (IRP) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.