Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia

Overview

This is a randomized study that sought to compare the rule-out capacity and antibiotics prescriptions associated with two different diagnostic imaging strategies (ultra-low-dose chest computed tomography versus chest radiography) in a group of healthy adults presenting to the emergency department (ED) with suspected community-acquired pneumonia (CAP).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2018

Detailed Description

Between October 2017 and December 2018, we prospectively enrolled consecutive adult patients with suspected community-acquired pneumonia based on at least one respiratory symptom and focal auscultatory findings and at least one sign related to infection, for whom no definitive diagnosis was possible by clinical judgment. Eligible patients were randomly assigned to their imaging evaluation in a 1:1 ratio to either ultra-low-dose chest computed tomography (ULDCT) or the standard evaluation strategy using conventional chest radiography (CR). This study sought to compare the rule-out capacity and antibiotics prescriptions associated with those two different diagnostic imaging strategies (ULDCT versus CR) in a group of healthy adult patients presenting to the ED with suspected CAP.

Interventions

  • Diagnostic Test: CR
    • Lung imaging evaluation performed with CR
  • Diagnostic Test: ULDCT
    • Lung imaging evaluation performed with ULDCT

Arms, Groups and Cohorts

  • Suspected community-acquired pneumonia patients
    • Suspected community-acquired pneumonia patients that will be evaluated by an imaging method

Clinical Trial Outcome Measures

Primary Measures

  • Community-acquired pneumonia rule-out capability
    • Time Frame: 1 month
    • Number of Participants for whom ULDCT could diagnose absence of imaging signs of pneumonia
  • Antibiotics prescription
    • Time Frame: immediate
    • Number of Participants for whom antibiotics were prescribed to treat bacterial pneumonia

Participating in This Clinical Trial

Inclusion Criteria

  • Suspected CAP; – At least one respiratory symptom (new or increasing cough, expectoration, dyspnea or chest pain) and – At least one symptom related to infection (fever ≥ 38°C, chills, sweating, myalgia, mental confusion or headache) and – Focal auscultatory findings during physical examinations (crackling rales) – No definitive diagnosis possible by clinical judgment. Exclusion Criteria:

  • Score in at least one clinical part of the CURB-65 or PSA scores – Clinical diagnosis of rhinosinusitis and acute nasopharyngitis and who had already been treated with antimicrobial therapy for this episode of disease – pregnancy; – the presence of other respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, chronic diseases or other chronic airway conditions; – diagnosis of congestive heart failure; – body mass index (BMI) greater than 30; – inability to hold the breath for at least 10 seconds

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Israelita Albert Einstein
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Sponsor

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