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

NCT04541160 | Completed FDA Device

• 1 other identifier: 3083
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumonia; Diagnoses Disease

Keywords

pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Suspected community-acquired pneumonia patients

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

Diagnostic Test: CR; Diagnostic Test: ULDCT

Interventions

CR DIAGNOSTIC_TEST

Lung imaging evaluation performed with CR

Suspected community-acquired pneumonia patients

ULDCT DIAGNOSTIC_TEST

Lung imaging evaluation performed with ULDCT

Suspected community-acquired pneumonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 18, 2020

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)