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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541160
• Other study ID #: 3083
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: October 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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