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).

Study Overview

• Status: Completed
• Conditions: Pneumonia; Diagnoses Disease
• Intervention / Treatment: Diagnostic test: CR; Diagnostic test: ULDCT

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.

• Study Type: Observational
• Enrollment (Actual): 237

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05652-900
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 211 patients were included from the 237 eligible ones. Sixteen patients refused to sign the informed consent form and five were excluded due to technical errors during image acquisition. Two patients exhibited BMIs higher than 35 and did not fulfil the inclusion criteria; three patients could not be reached for follow-up.

Among the 211 patients included, 98 (46.45%) were imaged by CR and 113 (53.55%) by ULDCT. There were no significant differences among patients in the CR and ULDCT groups concerning age, gender, height, weight, and BMI.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected community-acquired pneumonia patients; Suspected community-acquired pneumonia patients that will be evaluated by an imaging method	Diagnostic test: CR; Lung imaging evaluation performed with CR; Diagnostic test: ULDCT; Lung imaging evaluation performed with ULDCT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 3083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No