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

NCT06210282 | Completed

• 1 other identifier: N-20230038
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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.

• 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.

• 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.

• Satisfaction with the index consultation

  Day 0

• Antibiotics prescribed as delayed antibiotic prescription

  Day 0

Study Arms (2)

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

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.

Diagnostic Test: Focused lung ultrasound (FLUS); Other: Usual Care

Interventions

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 Care + Focused lung ultrasound (FLUS)

Usual Care OTHER

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 \[The Doctor's Handbook\].

Usual Care; Usual Care + Focused lung ultrasound (FLUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center for General Practice at Aalborg University

Gistrup, 9260, Denmark

Location

Related Publications (2)

• 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.

  PMID: 41035797 DERIVED

• Strom 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.

  PMID: 38698471 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Julie J Strøm, MD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: November 3, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 17, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)