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NCT04930926
Leukocyte Morphological Parameters as Prognostic Markers in CAP
trial in Pulmonary Disease in 1,200 participants. Status unknown.
30 December 2020
Quick facts
| Lead sponsor | Hospital Galdakao-Usansolo |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 1 November 2019 |
| Primary completion | 30 December 2020 |
| Estimated completion | 30 November 2021 |
| Sites | 1 location across Spain |
Conditions studied
- Pulmonary Disease — all drugs for Pulmonary Disease →
- Infection — all drugs for Infection →
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.
Verify or expand the search:
- PubMed search for NCT04930926
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04930926 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Galdakao-Usansolo
- Last refreshed: 18 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04930926.
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