PneumoniaNCT04541160
Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
An observational study of Pneumonia and Diagnoses Disease, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Diagnoses Disease
- What is being tested?
- CR and ULDCT
- How many people
- 237 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
About this study
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).
Read the 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.
- Conditions
- Pneumonia, Diagnoses Disease
- Being tested
- CR, ULDCT
- Keywords
- pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRDiagnostic test
Lung imaging evaluation performed with CR
ULDCTDiagnostic test
Lung imaging evaluation performed with ULDCT
| Study group | Role | What they receive |
|---|---|---|
| Suspected community-acquired pneumonia patients | Suspected community-acquired pneumonia patients that will be evaluated by an imaging method Receives: Diagnostic Test: CR; Diagnostic Test: ULDCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community-acquired pneumonia rule-out capability
Number of Participants for whom ULDCT could diagnose absence of imaging signs of pneumonia
Measured: 1 month
Antibiotics prescription
Number of Participants for whom antibiotics were prescribed to treat bacterial pneumonia
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Oct 2017
- Primary completion1 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541160
- Sponsor's protocol ID
- 3083
- Status last verified
- Oct 2017
- First submitted
- 1 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04541160
- Acronym / sponsor ID
- 3083
- Conditions
- Pneumonia, Diagnoses Disease
- Keywords
- pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected community-acquired pneumonia patients | – | Diagnostic Test: CR, Diagnostic Test: ULDCTSuspected community-acquired pneumonia patients that will be evaluated by an imaging method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRLung imaging evaluation performed with CR | Diagnostic test | Suspected community-acquired pneumonia patients |
| ULDCTLung imaging evaluation performed with ULDCT | Diagnostic test | Suspected community-acquired pneumonia patients |
Primary outcome
Community-acquired pneumonia rule-out capability
Time frame: 1 month
Number of Participants for whom ULDCT could diagnose absence of imaging signs of pneumonia
Antibiotics prescription
Time frame: immediate
Number of Participants for whom antibiotics were prescribed to treat bacterial pneumonia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Diagnoses Disease, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community-acquired pneumonia rule-out capability (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.