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Difference, IndividualTUS-STRATNCT03212248

CRP and Thoracic Emergency Ultrasound in Pneumonia

An observational study of Difference, Individual and Community-acquired Pneumonia, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Thoracic Ultrasound (TUS)
How many people
70 participants
Where
1 siteItaly
Study dates
2 Jan 2016to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Criteria of exclusion: severe respiratory failure - pulse oxymetry ≥92%, myocardial infarction, acute pulmonary edema or severe heart failure, excluded on clinical basis, severe COPD excluded by patient's history and by subsequent CXR, CURB65 ≥3.

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • MCAU

    Catania, Please Select An Option Below, 95131

Other trials in Italy

About this study

Official title: CRP (C-Reactive-Protein) and Pneumonia Biomarkers Stratification for Selectively Addressing Priorities in Thoracic Emergency Ultrasound in Pneumonia

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.

Read the detailed description

Chest-X-Rays (CXR), Computerized Tomography (CT) or Thoracic Ultrasound (TUS) provide images deemed consistent with acute lung consolidation and suitable to confirm the diagnosis of community acquired pneumonia (CAP). Patients which may be affected by CAP are many , but diagnosis is not straightforward because we are managing "a disease characterized by educated guesswork" . Comprehensive imaging workup may be not regularly affordable in busy emergency rooms. Point-of-care TUS allows reliable diagnosis of lung consolidation and of pleural effusion. Regretfully, adequate TUS expertise is more warranted than actually available in most medical departments. Even not specifically investigated, a delay or even an impairment of appropriate TUS or CXR evaluation for several patients may occur due to time- or resource-limiting factors.

Clinical clues of lung consolidation are many. Key symptoms are cough, fever, chest pain and dyspnea with tachypnea, while the major physical signs are chest crackles and dullness. Surrogate biomarkers more easily obtainable in emergency facilities are C-reactive-protein (CRP), peripheral non-invasive pulse-oxymetry and neutrophil-to-lymphocyte ratio (NLR) which is an index of systemic inflammation associated also with pneumonia and subsequent outcome.

The aim of this preliminary study is to evaluate if any clue and which biomarker, including NLR, assessed at Emergency Department (ED) triage, is predictive of the subsequent detection of lung consolidation by TUS and/or by CXR.

The minimal groups' size, with and without TUS or CXR lung consolidation, was calculated according to the difference of the averages of neutrophil-to-lymphocyte ratio (NLR) in the reference the study of Yoon et al. Accepting alpha 0.01, for the probability of type 1 error, and power 80% for probability of type 2 error, a minimum sample size of 19 participants in each group (total 38) was required. Student's t-tests assessed the differences of CRP, WBC - white blood cells count - (TLC), neutrophil count (TNC) and NLR, between the groups with TUS and, separately, with CXR lung consolidation.Thereafter, by ROC (receiver operating curve) analysis, a cutoff of NLR, total leucocytes count (TLC), total Neutrophil count (TNC) and of CRP was calculated vs. the optimal reliability for the detection of TUS consolidation; sensitivity, specificity and accuracy (The proportion of all tests that are correct), and relative Odds Ratio (OR) and confidence intervals (CI) of the individual symptoms, and ORs of so defined laboratory assay cut-offs were calculated separately vs. TUS and CXR consolidation.

Being tested
Thoracic Ultrasound (TUS)
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic Ultrasound (TUS)Diagnostic test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Odds of detecting lung consolidation by TUS according to symptoms or biomarkers' cutoffs

    ultrasound

    Measured: ten minutes

Secondary outcomes (1)

  1. Odds of detecting lung consolidation by Chest X Rays (CXR) according to symptoms or biomarkers' cutoffs

    radiology

    Measured: ten minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start2 Jan 2016
  3. Primary completion30 Apr 2016
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212248
Sponsor's protocol ID
TUS-STRAT
Acronym
TUS-STRAT
Status last verified
Jul 2017
First submitted
6 Jul 2017
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28223817

  • 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.

    PubMed 27742872

  • 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. doi: 10.4329/wjr.v8.i9.775.

    PubMed 27721940

  • 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. No abstract available.

    PubMed 27396790

  • 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. No abstract available.

    PubMed 26469839

  • 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 Aug;65(8):1796-1801. doi: 10.1111/jgs.14894. Epub 2017 Apr 13.

    PubMed 28407209

  • 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.

    PubMed 23482854

Questions about this trial

What is this clinical trial studying?

An observational study of Difference, Individual and Community-acquired Pneumonia, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds of detecting lung consolidation by TUS according to symptoms or biomarkers' cutoffs (time frame: ten minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03212248, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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