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Immunophenotype of Risk in Older Patients Admitted for Pneumonia

NCT ID: NCT04062799

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-09

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

no intervention

Intervention Type OTHER

It is an observationa study. There is no intervention.

Interventions

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no intervention

It is an observationa study. There is no intervention.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga H Torres, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sant Pau. Universitat Autònoma de Barcelona. Institut de Recerca Sant Pau.

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IIBSP-NEU-2018-118

Identifier Type: -

Identifier Source: org_study_id