Pneumonia Clinical Trial
Official title:
Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
NCT number | NCT04541160 |
Other study ID # | 3083 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | December 1, 2018 |
Verified date | October 2017 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelita Albert Einstein | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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 |
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