The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice (PLUS-FLUS)

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.

Study Overview

• Status: Completed
• Conditions: Community Acquired Pneumonia; Lower Respiratory Tract Infection
• Intervention / Treatment: Other: Usual Care; Diagnostic test: Focused lung ultrasound (FLUS)

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gistrup, Denmark, 9260
    • Center for General Practice at Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; 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	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].
Experimental: Usual Care + Focused lung ultrasound (FLUS); 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.	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].; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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
Antibiotics prescribed as delayed antibiotic prescription	Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).	Day 0
Antibiotics prescribed during follow-up	Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.	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.	Up until day 28.
Admission to hospital	Proportion of participants admitted to hospital within 28 days after index consultation.	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.	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.	Up until day 28.
Types of other imaging performed	Types of other imaging than FLUS performed within 28 days after index consultation.	Up until day 28.
Referred with suspicion of cancer	Proportion of participants referred with suspicion of cancer within 60 days after index consultation.	Up until day 60.
Diagnoses of cancer	Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.	Up until day 60.
Spontaneously reported unintended events	Number of spontaneously reported unintended events up until 60 days after index consultation.	Up until day 60.
Mortality	All-cause mortality up until day 28 and day 60.	Up until day 28 and 60.

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Julie J Strøm, MD, Center for General Practice at Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotics; General Practice; Lower Respiratory Tract Infection; Community Acquired Pneumonia; Point-of-care Ultrasound; Lung Ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pneumonia; Infections; Respiratory Tract Infections
• Other Study ID Numbers: N-20230038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No