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

Completed

• Conditions: Pneumonia; Diagnoses Disease
• Interventions: Diagnostic Test: CR; Diagnostic Test: ULDCT

• Registration Number: NCT04541160
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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).

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 Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-12-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected community-acquired pneumonia patients	ULDCT	Suspected community-acquired pneumonia patients that will be evaluated by an imaging method
Suspected community-acquired pneumonia patients	CR	Suspected community-acquired pneumonia patients that will be evaluated by an imaging method

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, SP, Brazil