Immunophenotype of Risk in Older Patients Admitted for Pneumonia

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062799
• Other study ID #: IIBSP-NEU-2018-118
• Status: Active, not recruiting
• Start date: May 9, 2019
• Est. completion date: January 2024

Study information

• Verified date: November 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: January 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Associated Immune Deficiency
• Elderly Infection
• Frail Elderly Syndrome
• Immunologic Deficiency Syndromes
• Nutrition Disorders
• Nutrition Disorders in Old Age
• Pneumonia
• Sarcopenia

Intervention

Other:
• no intervention
It is an observationa study. There is no intervention.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	Number of readmissions	To assess number of readmissions at 18 months.	18 months
Secondary	Immunological markers other than IRP	To evaluate if immunological markers other than IRP predispose to higher mortality or readmission rates	18 months
Secondary	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.	18 months
Secondary	Immunological alterations	To study if there is an association between IRP and clinical, functional, nutritional, comorbidity risk factors or frailty/sarcopenia.	18 months