The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice

Community Acquired Pneumonia Clinical Trial

— PLUS-FLUS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210282
• Other study ID #: N-20230038
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Aalborg University
• Contact: Julie J Strøm, MD
• Phone: 004520869389
• Email: jrjepsen[@]dcm.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 those given usual care only.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. Acute cough (< 21 days).

3. At least one other symptom of acute lower respiratory tract infection (LRTI).

4. The general practitioner suspects a bacterial community-acquired pneumonia.

Exclusion Criteria:

1. Previous antibiotic treatment for the current episode of acute LRTI.

2. The patient is not listed with the general practitioner (no medical record available).

3. The patient is not capable of understanding and signing informed consent.

4. The patient does not wish to participate in the study.

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Infections
• Lower Respiratory Tract Infection
• Pneumonia
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• 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.

Other:
• Usual Care
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].

Locations

Country	Name	City	State
Denmark	Center for General Practice at Aalborg University	Gistrup

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	Day 0
Secondary	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).	From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Secondary	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).	From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Secondary	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.	From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
Secondary	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.	Day 0
Secondary	Antibiotics prescribed as delayed antibiotic prescription	Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).	Day 0
Secondary	Antibiotics prescribed during follow-up	Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.	Up until day 28
Secondary	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.	Up until day 28.
Secondary	Admission to hospital	Proportion of participants admitted to hospital within 28 days after index consultation.	Up until day 28.
Secondary	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.	Up until day 28.
Secondary	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.	Up until day 28.
Secondary	Types of other imaging performed	Types of other imaging than FLUS performed within 28 days after index consultation.	Up until day 28.
Secondary	Referred with suspicion of cancer	Proportion of participants referred with suspicion of cancer within 60 days after index consultation.	Up until day 60.
Secondary	Diagnoses of cancer	Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.	Up until day 60.
Secondary	Spontaneously reported unintended events	Number of spontaneously reported unintended events up until 60 days after index consultation.	Up until day 60.
Secondary	Mortality	All-cause mortality up until day 28 and day 60.	Up until day 28 and 60.