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NCT04062799 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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