Community-acquired Pneumonia Clinical Trial
— TUS-STRATOfficial title:
CRP (C-Reactive-Protein) and Pneumonia Biomarkers Stratification for Selectively Addressing Priorities in Thoracic Emergency Ultrasound in Pneumonia
Verified date | July 2017 |
Source | Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This preliminary study investigates in patients with possible clinical diagnosis of pneumonia, clues and biomarker assessed at Emergency Department (ED) triage, potentially predicting detection of lung consolidation by Thoracic-ultrasound (TUS) and/or by Chest-X-Rays. Cough and high admission CRP levels will be defined according to the cutoff defined by ROC analysis, will be challenged if independently associated with TUS lung consolidation detection High level of the chosen biomarker, and any of the considered symptoms, in otherwise not extremely critical patients (CURB65≤3), should prompt to immediate confirm by TUS, during the physical examination. This may limit the need of further radiological investigations allowing targeted workup.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 30, 2017 |
Est. primary completion date | April 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility |
Inclusion Criteria: presence of history and symptoms, signs at physical examination and early laboratory clues of CAP According to the preliminary triage, in all patients, as a routine assessment, breath frequency, blood pressure and heart rate, pulse oxymetry, serum and blood analysis including creatinine and urea, CRP, blood cell counts and hemoglobin assay, were performed, also for CURB65 staging. ECG was preliminary done in all patients with chest pain, dyspnea and/or fever. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Italy | MCAU | Catania | Please select an option below |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele | Ospedale Civile di Ragusa, Italy |
Italy,
Cataudella E, Giraffa CM, Di Marca S, Pulvirenti A, Alaimo S, Pisano M, Terranova V, Corriere T, Ronsisvalle ML, Di Quattro R, Stancanelli B, Giordano M, Vancheri C, Malatino L. Neutrophil-To-Lymphocyte Ratio: An Emerging Marker Predicting Prognosis in Elderly Adults with Community-Acquired Pneumonia. J Am Geriatr Soc. 2017 Apr 13. doi: 10.1111/jgs.14894. [Epub ahead of print] — View Citation
Interrigi MC, Trovato FM, Catalano D, Trovato GM. Emergency thoracic ultrasound and clinical risk management. Ther Clin Risk Manag. 2017 Feb 9;13:151-160. doi: 10.2147/TCRM.S126770. eCollection 2017. — View Citation
Sperandeo M, Rea G, Grimaldi MA, Trovato F, Dimitri LM, Carnevale V. Contrast-enhanced ultrasound does not discriminate between community acquired pneumonia and lung cancer. Thorax. 2017 Feb;72(2):178-180. doi: 10.1136/thoraxjnl-2016-208913. Epub 2016 Oct 14. — View Citation
Trovato FM, Catalano D, Trovato GM. Thoracic ultrasound: An adjunctive and valuable imaging tool in emergency, resource-limited settings and for a sustainable monitoring of patients. World J Radiol. 2016 Sep 28;8(9):775-784. Review. — View Citation
Trovato FM, Catalano D. Diagnosis of Pneumonia by Lung Ultrasound in Children and Limited Resources Subsets: A Valuable Medical Breakthrough. Chest. 2016 Jul;150(1):258-60. doi: 10.1016/j.chest.2016.04.032. — View Citation
Waterer GW. The Diagnosis of Community-acquired Pneumonia. Do We Need to Take a Big Step Backward? Am J Respir Crit Care Med. 2015 Oct 15;192(8):912-3. doi: 10.1164/rccm.201507-1460ED. — View Citation
Yoon NB, Son C, Um SJ. Role of the neutrophil-lymphocyte count ratio in the differential diagnosis between pulmonary tuberculosis and bacterial community-acquired pneumonia. Ann Lab Med. 2013 Mar;33(2):105-10. doi: 10.3343/alm.2013.33.2.105. Epub 2013 Feb 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Odds of detecting lung consolidation by TUS according to symptoms or biomarkers' cutoffs | ultrasound | ten minutes | |
Secondary | Odds of detecting lung consolidation by Chest X Rays (CXR) according to symptoms or biomarkers' cutoffs | radiology | ten minutes |
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