Lower Respiratory Tract InfectionPLUS-FLUSNCT06210282
The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice
A study testing Focused lung ultrasound (FLUS) in people with Lower Respiratory Tract Infection and Community Acquired Pneumonia, run by Aalborg University at 1 site in Denmark.
Trial summary
The goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects CAP, who have FLUS performed as an addition to usual care, have antibiotics prescribed less frequent compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infection, Community Acquired Pneumonia
- What is being tested?
- Focused lung ultrasound (FLUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2023to 17 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Acute cough (< 21 days).
- At least one other symptom of acute lower respiratory tract infection (LRTI).
- The general practitioner suspects a bacterial community-acquired pneumonia.
Who cannot join
- Previous antibiotic treatment for the current episode of acute LRTI.
- The patient is not listed with the general practitioner (no medical record available).
- The patient is not capable of understanding and signing informed consent.
- The patient does not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in Patients With Acute Lower Respiratory Tract Infections in Danish General Practice: A Pragmatic Randomised Controlled Trial
The goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects CAP, who have FLUS performed as an addition to usual care, have antibiotics prescribed less frequent compared to those given usual care only.
- Being tested
- Focused lung ultrasound (FLUS), Usual Care
- Keywords
- Lower Respiratory Tract Infection, Community Acquired Pneumonia, Lung Ultrasound, Point-of-care Ultrasound, General Practice, Antibiotics
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused lung ultrasound (FLUS)Diagnostic test
We will use a 14-zone scanning approach. Each hemithorax is divided into anterior, lateral, and posterior surfaces. The anterior and lateral surfaces on each hemithorax are divided into an upper and lower quadrant. The posterior surfaces on each hemithorax are divided into an upper, middle, and lower quadrant. Each quadrant represents a scanning zone. Each scanning zone should be assessed using FLUS. The participating general practitioners use point-of-care ultrasound on a weekly basis before trial commencement and will use the ultrasonography device already available to them.
Usual CareOther
Participants assigned to the control group will receive the GP's usual care of adults (≥ 18 years) presenting with symptoms of an acute LRTI where the GP suspects CAP. Usual care will be used as a pragmatic comparator to reflect the current standard examinations and care of these patients in general practices in Denmark. Usual care is recommended to follow applicable guidelines from the Danish Society of General Practitioners (DSAM) and Lægehåndbogen [The Doctor's Handbook].
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants assigned to the usual care group will receive the general practitoner's usual care of adults (≥ 18 years) presenting with symptoms of an acute lower respiratory tract infection (LRTI) where the GP suspects community-acquired pneumonia. Usual care will be used as a pragmatic comparator to reflect the current standard examinations and care of this patient population in general practices in Denmark. Usual care is recommended to follow applicable guidelines from the Danish Society of General Practitioners and The Doctor's Handbook. Focused lung ultrasound (FLUS) is currently not standard or even a common examination in Danish general practices. Even for GPs already using point-of-care ultrasound on a weekly basis, FLUS is not part of usual care for adults presenting with symptoms of an acute LRTI Receives: Other: Usual Care |
| Usual Care + Focused lung ultrasound (FLUS) | Experimental | Participants assigned to the intervention group will receive a focused lung ultrasound examination (FLUS) during the index consultation (day 0) as an addition to usual care. Receives: Diagnostic Test: Focused lung ultrasound (FLUS); Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics prescribed at index consultation
The primary outcome is the proportion of participants with antibiotics prescribed at index consultation (day 0) reported by the GP at index consultation. We will assess the effect of adding FLUS to usual care on antibiotics prescribed at index consultation by investigating if there is a difference between groups in the proportion of participants with antibiotics prescribed at index consultation..
Measured: Day 0
Secondary outcomes (15)
Daily total LRTI symptom-score
Daily total LRTI symptom-score in groups, calculated as sum of scores of six symptoms (minimum 0 - maximum 36) (mean/median). Participants will be asked to complete a validated LRTI symptom diary every day from day 0 up until day 21. The recorded items include the following six symptoms of LRTI: cough, dyspnea, sputum production, well-being, sleep disturbance, and activity disturbance. The participants will be asked to consider how bad each symptom has been, over the past 24 hours by scoring each symptom on a 7-point Likert-scale (0 = no problem, 1 = very little problem, 2 = slight problem, 3 = moderate problem, 4 = bad problem, 5 = very bad problem, and 6 = as bad as it could be).
Measured: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days with symptoms being a "moderate problem" or worse
Number of days with symptoms rated a "moderate problem" or worse by the participants in groups (at least one item with score 3 or above) (mean/median).
Measured: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days signed in sick/cancelled work-related activities
Number of days participants signed in sick/cancelled work-related activities or cancelled leisure activities (mean/median) in groups.
Measured: From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Satisfaction with the index consultation
Proportion of participants satisfied or very satisfied (4 or 5) with the index consultation on a 5-point Likert scale.
Measured: Day 0
Antibiotics prescribed as delayed antibiotic prescription
Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).
Measured: Day 0
Antibiotics prescribed during follow-up
Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.
Measured: Up until day 28
Re-consultations
Proportion of participants with re-consultations, defined as any primary care contacts (general practice or out-of-hour services), within 28 days after index consultation.
Measured: Up until day 28.
Admission to hospital
Proportion of participants admitted to hospital within 28 days after index consultation.
Measured: Up until day 28.
Complications
Proportion of participants with complications (pleural infection (defined as complicated parapneumonic effusion or empyema), lung abscess, or sepsis) during admission to hospital within 28 days after index consultation.
Measured: Up until day 28.
Other imaging than FLUS performed
Proportion of participants with other imaging than FLUS (any imaging performed in secondary health care services) performed within 28 days after index consultation.
Measured: Up until day 28.
Types of other imaging performed
Types of other imaging than FLUS performed within 28 days after index consultation.
Measured: Up until day 28.
Referred with suspicion of cancer
Proportion of participants referred with suspicion of cancer within 60 days after index consultation.
Measured: Up until day 60.
Diagnoses of cancer
Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.
Measured: Up until day 60.
Spontaneously reported unintended events
Number of spontaneously reported unintended events up until 60 days after index consultation.
Measured: Up until day 60.
Mortality
All-cause mortality up until day 28 and day 60.
Measured: Up until day 28 and 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start3 Nov 2023
- Primary completion1 Aug 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Jepsen Strøm, Aalborg University
- Investigators
- Julie J Strøm, MD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210282
- Sponsor's protocol ID
- N-20230038
- Acronym
- PLUS-FLUS
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strom JJ, Andersen CA, Bach Jensen M, Laust Thomsen J, Laursen CB, Skaarup SH, Lawaetz Schultz HH, Hansen MP. The effect of focused lung ultrasound on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice (PLUS-FLUS): a pragmatic, randomised controlled, post-market trial. EClinicalMedicine. 2025 Sep 18;88:103518. doi: 10.1016/j.eclinm.2025.103518. eCollection 2025 Oct.
PubMed 41035797Strom JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, Hansen MP. The effect of focused lung ultrasonography on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice: study protocol for a pragmatic randomized controlled trial (PLUS-FLUS). Trials. 2024 May 2;25(1):298. doi: 10.1186/s13063-024-08129-2.
PubMed 38698471
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in Patients With Acute Lower Respiratory Tract Infections in Danish General Practice: A Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06210282
- Acronym / sponsor ID
- PLUS-FLUS / N-20230038
- Keywords
- Lower Respiratory Tract Infection, Community Acquired Pneumonia, Lung Ultrasound, Point-of-care Ultrasound, General Practice, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 18 Jan 2024 (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.
The goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects CAP, who have FLUS performed as an addition to usual care, have antibiotics prescribed less frequent compared to those given usual care only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareParticipants assigned to the usual care group will receive the general practitoner's usual care of adults (≥ 18 years) presenting with symptoms of an acute lower respiratory tract infection (LRTI) where the GP suspects community-acquired pneumonia. Usual care will be used as a pragmatic comparator to reflect the current standard examinations and care of this patient population in general practices in Denmark. Usual care is recommended to follow applicable guidelines from the Danish Society of General Practitioners and The Doctor's Handbook. Focused lung ultrasound (FLUS) is currently not standard or even a common examination in Danish general practices. Even for GPs already using point-of-care ultrasound on a weekly basis, FLUS is not part of usual care for adults presenting with symptoms of an acute LRTI |
| Usual Care + Focused lung ultrasound (FLUS) | Experimental | Diagnostic Test: Focused lung ultrasound (FLUS), Other: Usual CareParticipants assigned to the intervention group will receive a focused lung ultrasound examination (FLUS) during the index consultation (day 0) as an addition to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Acute cough (< 21 days).
- At least one other symptom of acute lower respiratory tract infection (LRTI).
- The general practitioner suspects a bacterial community-acquired pneumonia.
Key exclusion criteria (4 listed)
- Previous antibiotic treatment for the current episode of acute LRTI.
- The patient is not listed with the general practitioner (no medical record available).
- The patient is not capable of understanding and signing informed consent.
- The patient does not wish to participate in 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 |
|---|---|---|
| Focused lung ultrasound (FLUS)We will use a 14-zone scanning approach. Each hemithorax is divided into anterior, lateral, and posterior surfaces. The anterior and lateral surfaces on each hemithorax are divided into an upper and lower quadrant. The posterior surfaces on each hemithorax are divided into an upper, middle, and lower quadrant. Each quadrant represents a scanning zone. Each scanning zone should be assessed using FLUS. The participating general practitioners use point-of-care ultrasound on a weekly basis before trial commencement and will use the ultrasonography device already available to them. | Diagnostic test | Usual Care + Focused lung ultrasound (FLUS) |
| Usual CareParticipants assigned to the control group will receive the GP's usual care of adults (≥ 18 years) presenting with symptoms of an acute LRTI where the GP suspects CAP. Usual care will be used as a pragmatic comparator to reflect the current standard examinations and care of these patients in general practices in Denmark. Usual care is recommended to follow applicable guidelines from the Danish Society of General Practitioners (DSAM) and Lægehåndbogen [The Doctor's Handbook]. | Other | Usual Care, Usual Care + Focused lung ultrasound (FLUS) |
Primary outcome
Antibiotics prescribed at index consultation
Time frame: Day 0
The primary outcome is the proportion of participants with antibiotics prescribed at index consultation (day 0) reported by the GP at index consultation. We will assess the effect of adding FLUS to usual care on antibiotics prescribed at index consultation by investigating if there is a difference between groups in the proportion of participants with antibiotics prescribed at index consultation..
15 secondary outcomes
Daily total LRTI symptom-score
Time frame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days with symptoms being a "moderate problem" or worse
Time frame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Days signed in sick/cancelled work-related activities
Time frame: From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Satisfaction with the index consultation
Time frame: Day 0
Antibiotics prescribed as delayed antibiotic prescription
Time frame: Day 0
Antibiotics prescribed during follow-up
Time frame: Up until day 28
Re-consultations
Time frame: Up until day 28.
Admission to hospital
Time frame: Up until day 28.
Complications
Time frame: Up until day 28.
Other imaging than FLUS performed
Time frame: Up until day 28.
Types of other imaging performed
Time frame: Up until day 28.
Referred with suspicion of cancer
Time frame: Up until day 60.
Diagnoses of cancer
Time frame: Up until day 60.
Spontaneously reported unintended events
Time frame: Up until day 60.
Mortality
Time frame: Up until day 28 and 60.
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 29 Nov 2024.
- Derived from this study: PubMed 41035797Strom JJ, Andersen CA, Bach Jensen M, Laust Thomsen J, Laursen CB, Skaarup SH, Lawaetz Schultz HH, Hansen MP. The effect of focused lung ultrasound on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice (PLUS-FLUS): a pragmatic, randomised controlled, post-market trial. EClinicalMedicine. 2025 Sep 18;88:103518. doi: 10.1016/j.eclinm.2025.103518. eCollection 2025 Oct.
- Derived from this study: PubMed 38698471Strom JJ, Andersen CA, Jensen MB, Thomsen JL, Laursen CB, Skaarup SH, Schultz HHL, Hansen MP. The effect of focused lung ultrasonography on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice: study protocol for a pragmatic randomized controlled trial (PLUS-FLUS). Trials. 2024 May 2;25(1):298. doi: 10.1186/s13063-024-08129-2.
- Individual participant dataSharing planned: No
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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.
Julie J Strøm, MD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused lung ultrasound (FLUS) in people with Lower Respiratory Tract Infection and Community Acquired Pneumonia, run by Aalborg University at 1 site in Denmark.
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 4 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 29 Nov 2024. 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 Denmark. 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?
Antibiotics prescribed at index consultation (time frame: Day 0). 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 NCT06210282, which also lists 2 linked publications.
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 29 Nov 2024.