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OpenTrials
Completed

NCT Number: NCT04541160

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CR

Diagnostic Test

Lung imaging evaluation performed with CR

ULDCT

Diagnostic Test

Lung imaging evaluation performed with ULDCT

Primary outcomes

  1. Community-acquired pneumonia rule-out capability

    Time frame: 1 month

    Number of Participants for whom ULDCT could diagnose absence of imaging signs of pneumonia

  2. Antibiotics prescription

    Time frame: immediate

    Number of Participants for whom antibiotics were prescribed to treat bacterial pneumonia

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2020
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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