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Leukocyte Morphological Parameters as Prognostic Markers in CAP

NCT04930926 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2021-06-18

No results posted yet for this study

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

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • PEDRO PABLO ESPAÑA YANDIOLA, PhD · CHIEF OF PNEUMOLOGY SERVICE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-12-30
Completion
2021-11-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930926 on ClinicalTrials.gov