Leukocyte Morphological Parameters as Prognostic Markers in CAP

NCT04930926 | Unknown DMC

• 1 other identifier: 2018111033
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

An innovative multicenter project that aims to study the evolution and predictive value of new leukocyte morphological parameters (CPD) in patients with community-acquired pneumonia. Our project has 3 objectives: 1.- To demonstrate that the use of some leukocyte morphology parameters at the time of diagnosis, and their changes in the first 72 hours, can help us to better identify the severity and prognosis of these patients and to discriminate between bacterial etiology of viral. 2.- Make a comparison with other more studied inflammation and cardiovascular biomarkers such as C-reactive protein, pro-calcitonin and pro-adrenomedullin. 3.- Incorporate some of these CPDs parameters to a new prediction rule with greater sensitivity and specificity than those existing up to now (PSI, CURB-65, SCAP, ATS / IDSA). Methodology: The study will be carried out in 3 hospitals (Galdakao-Usánsolo, Basurto and San Pedro de Logroño). Prospective observational study with longitudinal follow-up up to 30 days after the diagnosis of admitted patients with CAP. Patients will be included consecutively for 24 months; Sociodemographic variables, duration of symptoms, previous antibiotic therapy, severity of presentation, etiological diagnosis, treatment administered and evolution during hospital stay and up to 30 days will be analyzed. As dependent variables of severe CAP we will use, on the one hand, poor evolution (therapeutic failure, and / or need for admission to high-monitoring units such as ICU or Intermediate Respiratory Care Unit (ICU) and / or 30-day mortality) and, for another, a microbiological etiological diagnosis. For statistical processing, univariate and multivariate analyzes and logistic regression models will be used to create a predictive rule.

Conditions

Pulmonary Disease; Infection

Keywords

PNEUMONIA; LEUKOCYTES; MORPHOLOGICAL CHANGES

Outcome Measures

Primary Outcomes (1)

• ETIOLOGY

  THE ETIOLOGY OF PATIENTS TO WATCH THE EVOLUTION

  INDEX ADMISSION TO 30 DAYS

Secondary Outcomes (1)

• MORTALITY

  ONE YEAR

Other Outcomes (1)

• BAD EVOLUTION

  INDEX ADMISSION TO 30 DAYS

Study Arms (1)

INFECTION DISEASE PATIENTS WITH PNEUMONIA OR SARHS COVID19

NO SPECIFIC INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an pneumonia or SARHS COVID 19 admitted to any of the participant hospitals; Galdakao-Usansolo Hospital, Basurto Hospital (basque country) and San Pedro Logroño Hospital (La Rioja). During the recruitment period who fulffill the selection criteria until the desired sample size is obtained.

You may qualify if:

• PNEUMONIA PATIENTS SARHS COVID 19 PATIENTS

You may not qualify if:

• LESS THAN 18 YEARS OLD IMMUNE DEPRESSED PATIENTS

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Iñaki Arriaga

Bilbao, Bizkaia, 48002, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In three of the hospital participant a sample of blood has been collected in each index admission and stored in each Biobank with the purpose of stuying some biomarkers of inflamation. In these cases, the patient must sign a specific additional informed consent established by the Biobank. With each Biobank the method will be established for the recruitment and delivery of samples.

MeSH Terms

Conditions

Lung Diseases; Infections; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections

Study Officials

• PEDRO PABLO ESPAÑA YANDIOLA, PhD

  CHIEF OF PNEUMOLOGY SERVICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PEDRO PABLO ESPAÑA YANDIOLA, PhD

CONTACT

+34944007002; PEDROPABLO.ESPANAYANDIOLA@OSAKIDETZA.EUS

NAGORE PEREZ GARCIA

CONTACT

+34944007002; NAGORE.PEREZGARCIA@OSAKIDETZA.EUS

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF EPIDEMIOLOGY SERVICE

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: November 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: November 30, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

ES (1)