Acute Respiratory Tract InfectionNCT05175612
Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
An observational study of Acute Respiratory Tract Infection, run by Healthy Networks at 1 site in Belarus.
Trial summary
This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI) Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Lung auscultation with LungPass device (electronic auscultation)
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteBelarus
- Study dates
- 16 Nov 2021to 30 Nov 2022
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recruited in primary care settings upon presentation with symptoms of acute respiratory infection. It is planned to start recruiting 100 adult patients and 100 children with URTI and 100 adults and 100 children with LRTI. The final calculation of the sample size will be carried out after receiving the preliminary results of the study. After that, the sample size will be adjusted.
Who may be able to join
- Adults (over 18 years) and children (3-18 years) of both sexes;
- Patients able and willing to sign an informed consent to participate in the study (parents of children younger than 18 years old will be allowed to give an informed consent on behalf of their children).
- Patients presenting with a new onset of at least two of listed acute respiratory tract infection symptoms within the last 5 days: cough, purulent sputum, breathlessness, core temperature above 38°C.
- Patients who first visit a GP with these symptoms within the first 5 days from the onset of symptoms and was not previously treated with antibiotics during the last month.
Who cannot join
- Age up to 3 years;
- Patient refusal to participate in the study (or patients' parents);
- Children under full State care (orphans, children left without parental care);
- Treatment with antibiotics during the last month;
- Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
- Presence of other known chronic lung conditions such as asthma, COPD, tuberculosis, cystic fibrosis or bronchiectasis;
- Mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure.
- Other known ongoing infection.
Trial locations and contacts
1 site in 1 country.
Belarus1 site
19th Сentral District Polyclinic of Pervomaisky District of Minsk
Minsk, 220114
About this study
This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)
Read the detailed description
This is a prospective observational study comprised patients presenting with acute respiratory tract infection symptoms in primary care settings. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, result of diagnostic questionnaire from the LungPass App, complete blood count, C-reactive protein, procalcitonin (PCT) level, SARS-CoV-2 PCR test and X-ray chest examination or CT chest (in case of preliminary clinical suspicion of LRTI). Patients will be followed up within 5-7 days and at the end of the disease in person or by phone for clinical course of the disease assessment to confirm the final diagnosis (URTI or LRTI). Final diagnosis will be considered as Gold standard for accuracy assessment.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- Lung auscultation with LungPass device (electronic auscultation)
- Keywords
- Lung sound analysis, Upper Respiratory Truct Infections, Lower Respiratory Truct Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung auscultation with LungPass device (electronic auscultation)Device
Lung auscultation with electronic stethoscope
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of identifying LRTI by abnormal lung sounds
Accuracy of differentiation between ULRTI and LRTI by abnormal lung sounds detected with LungPass device
Measured: 16.11.2021- 30.11.2021
Secondary outcomes (2)
Accuracy of identifying LRTI by abnormal lung sounds in subgroups with COVID-19 and non-COVID-19 LRTI
Accuracy of differentiation between ULRTI and LRTI by abnormal lung sounds detected with LungPass device in subgroups with COVID-19 and non-COVID-19 LRTI
Measured: 16.11.2021- 30.11.2021
Lung sounds and clinical signs of LRTI correlation in patients with LRTI
Correlation between presence of pathological pulmonary sounds detected with LungPass device and presence of clinical signs of LRTI (clinical parameters/radiology results) in patients with LRTI
Measured: 16.11.2021- 30.11.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start16 Nov 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Why it stopped: For sponsor reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthy Networks
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Helena Binetskaya, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175612
- Sponsor's protocol ID
- № 4-3/YH-2056/LP06
- Status last verified
- Jun 2022
- First submitted
- 26 Nov 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
- ClinicalTrials.gov ID
- NCT05175612
- Acronym / sponsor ID
- № 4-3/YH-2056/LP06
- Conditions
- Acute Respiratory Tract Infection
- Keywords
- Lung sound analysis, Upper Respiratory Truct Infections, Lower Respiratory Truct Infections
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: For sponsor reasons
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Healthy NetworksIndustry (pharma, biotech, devices)
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education, University of Manchester
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 4 Jan 2022 (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 observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)
Detailed description
This is a prospective observational study comprised patients presenting with acute respiratory tract infection symptoms in primary care settings. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, result of diagnostic questionnaire from the LungPass App, complete blood count, C-reactive protein, procalcitonin (PCT) level, SARS-CoV-2 PCR test and X-ray chest examination or CT chest (in case of preliminary clinical suspicion of LRTI). Patients will be followed up within 5-7 days and at the end of the disease in person or by phone for clinical course of the disease assessment to confirm the final diagnosis (URTI or LRTI). Final diagnosis will be considered as Gold standard for accuracy assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited in primary care settings upon presentation with symptoms of acute respiratory infection. It is planned to start recruiting 100 adult patients and 100 children with URTI and 100 adults and 100 children with LRTI. The final calculation of the sample size will be carried out after receiving the preliminary results of the study. After that, the sample size will be adjusted.
Key inclusion criteria (4 listed)
- Adults (over 18 years) and children (3-18 years) of both sexes;
- Patients able and willing to sign an informed consent to participate in the study (parents of children younger than 18 years old will be allowed to give an informed consent on behalf of their children).
- Patients presenting with a new onset of at least two of listed acute respiratory tract infection symptoms within the last 5 days: cough, purulent sputum, breathlessness, core temperature above 38°C.
- Patients who first visit a GP with these symptoms within the first 5 days from the onset of symptoms and was not previously treated with antibiotics during the last month.
Key exclusion criteria (8 listed)
- Age up to 3 years;
- Patient refusal to participate in the study (or patients' parents);
- Children under full State care (orphans, children left without parental care);
- Treatment with antibiotics during the last month;
- Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
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 |
|---|---|---|
| Lung auscultation with LungPass device (electronic auscultation)Lung auscultation with electronic stethoscope | Device | – |
Primary outcome
Accuracy of identifying LRTI by abnormal lung sounds
Time frame: 16.11.2021- 30.11.2021
Accuracy of differentiation between ULRTI and LRTI by abnormal lung sounds detected with LungPass device
2 secondary outcomes
Accuracy of identifying LRTI by abnormal lung sounds in subgroups with COVID-19 and non-COVID-19 LRTI
Time frame: 16.11.2021- 30.11.2021
Lung sounds and clinical signs of LRTI correlation in patients with LRTI
Time frame: 16.11.2021- 30.11.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Helena Binetskaya study director
CEO
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 Acute Respiratory Tract Infection, run by Healthy Networks at 1 site in Belarus.
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 4 inclusion and 8 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: paused, as of the sponsor's last update on 7 Jun 2022. 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 Belarus. 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?
Results are not available in the source record.
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?
Accuracy of identifying LRTI by abnormal lung sounds (time frame: 16.11.2021- 30.11.2021). 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 7 Jun 2022.