Clinical trial NCT06210282: The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Respiratory Tract Infection
Community Acquired Pneumonia
Keywords: Lower Respiratory Tract Infection
Community Acquired Pneumonia
Lung Ultrasound
Point-of-care Ultrasound
General Practice
Antibiotics
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Antibiotics prescribed at index consultation
timeFrame: Day 0
Secondary outcomes:
measure: Daily total LRTI symptom-score
timeFrame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
measure: Days with symptoms being a "moderate problem" or worse
timeFrame: From day 0 until participants have scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
measure: Days signed in sick/cancelled work-related activities
timeFrame: From day 0 until the participant has scored 0 in every symptom item, whichever comes first, or up to a maximum of day 21.
measure: Satisfaction with the index consultation
timeFrame: Day 0
measure: Antibiotics prescribed as delayed antibiotic prescription
timeFrame: Day 0
measure: Antibiotics prescribed during follow-up
timeFrame: Up until day 28
measure: Re-consultations
timeFrame: Up until day 28.
measure: Admission to hospital
timeFrame: Up until day 28.
measure: Complications
timeFrame: Up until day 28.
measure: Other imaging than FLUS performed
timeFrame: Up until day 28.
measure: Types of other imaging performed
timeFrame: Up until day 28.
measure: Referred with suspicion of cancer
timeFrame: Up until day 60.
measure: Diagnoses of cancer
timeFrame: Up until day 60.
measure: Spontaneously reported unintended events
timeFrame: Up until day 60.
measure: Mortality
timeFrame: Up until day 28 and 60.
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Center for General Practice at Aalborg University
Study officials:
affiliation: Aalborg University
name: Julie J Strøm, MD
role: PRINCIPAL_INVESTIGATOR
References: