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

NCT ID: NCT06210282

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2024-10-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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 + 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.

Group Type: EXPERIMENTAL

Focused lung ultrasound (FLUS)

Intervention Type: 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

Intervention Type: 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 \[The Doctor's Handbook\].

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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 \[The Doctor's Handbook\].

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Julie Jepsen Strøm

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie J Strøm, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Center for General Practice at Aalborg University

Gistrup, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 41035797 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38698471 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

N-20230038

Identifier Type: -

Identifier Source: org_study_id