Immunophenotype of Risk in Older Patients Admitted for Pneumonia

NCT04062799 | Unknown

• 1 other identifier: IIBSP-NEU-2018-118
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of readmissions

  18 months

• Immunological markers other than IRP

  18 months

• Immunological profile

  18 months

• Immunological alterations

  18 months

Study Arms (1)

Study cohort

Other: no intervention

Interventions

no intervention OTHER

It is an observationa study. There is no intervention.

Study cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• patients ≥ 65 years old admitted for pneumonia in the "Hospital de la Santa Creu i Sant Pau in Barcelona".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pneumonia; Sarcopenia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Olga H Torres, PhD MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: August 20, 2019
• Study Start: May 9, 2019
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

ES (1)