Immunophenotype of Risk in Older Patients Admitted for Pneumonia

• Conditions: Nutrition Disorders in Old Age; Sarcopenia; Age Associated Immune Deficiency; Elderly Infection; Pneumonia; Frail Elderly Syndrome
• Interventions: Other: no intervention

• Registration Number: NCT04062799
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study Start: 2019-05-09
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23
• Primary Completion: 2023-07
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	no intervention	-

Primary Outcome Measures

Name	Time	Method
Presence of the immune risk phenotype (IRP)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain