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Immunophenotype of Risk in Older Patients Admitted for Pneumonia

Identification of an Immunophenotype of Risk of Poor Prognosis in Elderly Patients Who Have Been Admitted for Pneumonia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04062799
Enrollment
174
Registered
2019-08-20
Start date
2019-05-09
Completion date
2024-01-31
Last updated
2021-11-23

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

Conditions

Age Associated Immune Deficiency, Elderly Infection, Frail Elderly Syndrome, Nutrition Disorders in Old Age, Pneumonia, Sarcopenia

Brief 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. 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.

Interventions

OTHERno intervention

It is an observationa study. There is no intervention.

Sponsors

Fondo de Investigacion Sanitaria
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients ≥ 65 years old admitted for pneumonia in the Hospital de la Santa Creu i Sant Pau in Barcelona.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Presence of the immune risk phenotype (IRP)18 monthsTo 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.

Secondary

MeasureTime frameDescription
Number of readmissions18 monthsTo assess number of readmissions at 18 months.
Immunological markers other than IRP18 monthsTo evaluate if immunological markers other than IRP predispose to higher mortality or readmission rates
Immunological profile18 monthsTo describe the basic immunological profile of the elderly who have been admitted due to pneumonia and its evolution after the acute phase.
Immunological alterations18 monthsTo study if there is an association between IRP and clinical, functional, nutritional, comorbidity risk factors or frailty/sarcopenia.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026