Clinical trial NCT04062799: Immunophenotype of Risk in Older Patients Admitted for Pneumonia
Official title: Identification of an Immunophenotype of Risk of Poor Prognosis in Elderly Patients Who Have Been Admitted for Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age Associated Immune Deficiency
Elderly Infection
Pneumonia
Nutrition Disorders in Old Age
Frail Elderly Syndrome
Sarcopenia
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2019-08-20
Enrollment: 174
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of the immune risk phenotype (IRP)
timeFrame: 18 months
Secondary outcomes:
measure: Number of readmissions
timeFrame: 18 months
measure: Immunological markers other than IRP
timeFrame: 18 months
measure: Immunological profile
timeFrame: 18 months
measure: Immunological alterations
timeFrame: 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hospital de Sant Pau. Universitat Autònoma de Barcelona. Institut de Recerca Sant Pau.
name: Olga H Torres, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: