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

Not Applicable

Completed

• Conditions: Community Acquired Pneumonia; Lower Respiratory Tract Infection
• Interventions: Other: Usual Care; Diagnostic Test: Focused lung ultrasound (FLUS)

• Registration Number: NCT06210282
• Lead Sponsor: Aalborg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-03
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Primary Completion: 2024-08-01
• Study Completion: 2024-10-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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
Usual Care + Focused lung ultrasound (FLUS)	Usual Care	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.
Usual Care + Focused lung ultrasound (FLUS)	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.

Primary Outcome Measures

Name	Time	Method
Antibiotics prescribed at index consultation	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..

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the index consultation	Day 0	Proportion of participants satisfied or very satisfied (4 or 5) with the index consultation on a 5-point Likert scale.
Antibiotics prescribed during follow-up	Up until day 28	Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.
Complications	Up until day 28.	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.
Days with symptoms being a "moderate problem" or worse	From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.	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).
Admission to hospital	Up until day 28.	Proportion of participants admitted to hospital within 28 days after index consultation.
Spontaneously reported unintended events	Up until day 60.	Number of spontaneously reported unintended events up until 60 days after index consultation.
Daily total LRTI symptom-score	From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.	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).
Days signed in sick/cancelled work-related activities	From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.	Number of days participants signed in sick/cancelled work-related activities or cancelled leisure activities (mean/median) in groups.
Antibiotics prescribed as delayed antibiotic prescription	Day 0	Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).
Re-consultations	Up until day 28.	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.
Types of other imaging performed	Up until day 28.	Types of other imaging than FLUS performed within 28 days after index consultation.
Referred with suspicion of cancer	Up until day 60.	Proportion of participants referred with suspicion of cancer within 60 days after index consultation.
Diagnoses of cancer	Up until day 60.	Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.
Other imaging than FLUS performed	Up until day 28.	Proportion of participants with other imaging than FLUS (any imaging performed in secondary health care services) performed within 28 days after index consultation.
Mortality	Up until day 28 and 60.	All-cause mortality up until day 28 and day 60.

Trial Locations

Locations (1)

Center for General Practice at Aalborg University; 🇩🇰 Gistrup, Denmark