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NCT04930926

Leukocyte Morphological Parameters as Prognostic Markers in CAP

Status unknown Last updated 18 June 2021
What this trial tests

trial in Pulmonary Disease in 1,200 participants. Status unknown.

Timeline
1 November 2019
Primary endpoint
30 December 2020
30 November 2021

Quick facts

Lead sponsorHospital Galdakao-Usansolo
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,200
Start date1 November 2019
Primary completion30 December 2020
Estimated completion30 November 2021
Sites1 location across Spain

Conditions studied

Sponsor

Hospital Galdakao-Usansolo

Who can join

18 and older, any sex, with Pulmonary Disease or Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pulmonary Disease

Currently open trials in the same condition.

Other Hospital Galdakao-Usansolo trials

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