Lower Resp Tract InfectionAmbuLUSNCT04602234
Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice
A study testing Lung ultrasonography in people with Lower Resp Tract Infection and Ultrasound Therapy; Complications, run by University Hospital, Caen at 1 site in France.
Trial summary
Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Lower Resp Tract Infection, Ultrasound Therapy; Complications
- What is being tested?
- Lung ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2019to 18 Mar 2020
- Phase
- Interventional
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 3 months
- Dyspnea or cough complaint
Who cannot join
- Age < 3 months
- Rejection to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study
Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.
The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.
Read more
This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.
The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.
Read the detailed description
After an initial medical report, GP's concluded to an initial diagnosis and make initial prescription and finally decided or not to perform a standardized eight-points LUS. GP were free to perform or not LUS. If GP decided to perform LUS, GP were allowed to change their diagnosis and prescriptions (LUS group). However, therapeutic changes after LUS could not "downgrade" patient care.
- Being tested
- Lung ultrasonography
- Keywords
- Lung ultrasonography, Lower Respiratory Tract Infection, General Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasonographyDiagnostic test
Investigators performed lung ultrasonography on patients
| Study group | Role | What they receive |
|---|---|---|
| LUS group | Experimental | Not described Receives: Diagnostic Test: Lung ultrasonography |
| No LUS group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis modification
Diagnosis modification after lung ultrasonography
Measured: 3 months
Secondary outcomes (5)
Therapeutic modification
Therapeutic modification after lung ultrasonography
Measured: 3 months
Imagery prescription
Decision of imagery prescription after lung ultrasonography
Measured: 3 months
Decision of hospitalization
Decision of an hospitalization or not after lung ultrasonography
Measured: 3 months
Medical evolution
Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)
Measured: 3 months
Imagery result
Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start30 Dec 2019
- Primary completion11 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Resp Tract InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Among the 151 patients included, 111 LUS were performed (LUS group)
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602234
- Sponsor's protocol ID
- 2019-A00205)52
- Acronym
- AmbuLUS
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amiot F, Delomas T, Laborne FX, Ecolivet T, Macrez R, Benhamed A. Implementation of lung ultrasonography by general practitioners for lower respiratory tract infections: a feasibility study. Scand J Prim Health Care. 2024 Sep;42(3):463-470. doi: 10.1080/02813432.2024.2343678. Epub 2024 May 20.
PubMed 38767949
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study
- ClinicalTrials.gov ID
- NCT04602234
- Acronym / sponsor ID
- AmbuLUS / 2019-A00205)52
- Keywords
- Lung ultrasonography, Lower Respiratory Tract Infection, General Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 26 Oct 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.
Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.
The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.
This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.
The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.
Detailed description
After an initial medical report, GP's concluded to an initial diagnosis and make initial prescription and finally decided or not to perform a standardized eight-points LUS. GP were free to perform or not LUS. If GP decided to perform LUS, GP were allowed to change their diagnosis and prescriptions (LUS group). However, therapeutic changes after LUS could not "downgrade" patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Among the 151 patients included, 111 LUS were performed (LUS group)
| Arm | Type | Receives |
|---|---|---|
| LUS group | Experimental | Diagnostic Test: Lung ultrasonography |
| No LUS group | No intervention | – |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 3 months
- Dyspnea or cough complaint
Key exclusion criteria (2 listed)
- Age < 3 months
- Rejection to participate to the study
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 ultrasonographyInvestigators performed lung ultrasonography on patients | Diagnostic test | LUS group |
Primary outcome
Diagnosis modification
Time frame: 3 months
Diagnosis modification after lung ultrasonography
5 secondary outcomes
Therapeutic modification
Time frame: 3 months
Imagery prescription
Time frame: 3 months
Decision of hospitalization
Time frame: 3 months
Medical evolution
Time frame: 3 months
Imagery result
Time frame: 3 months
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 26 Oct 2020.
- Derived from this study: PubMed 38767949Amiot F, Delomas T, Laborne FX, Ecolivet T, Macrez R, Benhamed A. Implementation of lung ultrasonography by general practitioners for lower respiratory tract infections: a feasibility study. Scand J Prim Health Care. 2024 Sep;42(3):463-470. doi: 10.1080/02813432.2024.2343678. Epub 2024 May 20.
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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?
A study testing Lung ultrasonography in people with Lower Resp Tract Infection and Ultrasound Therapy; Complications, run by University Hospital, Caen at 1 site in France.
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 2 inclusion and 2 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 26 Oct 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 France. 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?
Diagnosis modification (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602234, which also lists 1 linked publication.
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 26 Oct 2020.