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Completed

NCT Number: NCT06210282

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

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.

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Key information

Conditions

Lower Respiratory Tract Infection Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for General Practice at Aalborg University

Gistrup, 9260, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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].

Primary outcomes

  1. Antibiotics prescribed at index consultation

    Time frame: 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 outcomes

  1. Daily total LRTI symptom-score

    Time frame: 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).

  2. Days with symptoms being a "moderate problem" or worse

    Time frame: 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).

  3. Days signed in sick/cancelled work-related activities

    Time frame: 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.

  4. Satisfaction with the index consultation

    Time frame: Day 0

    Proportion of participants satisfied or very satisfied (4 or 5) with the index consultation on a 5-point Likert scale.

  5. Antibiotics prescribed as delayed antibiotic prescription

    Time frame: Day 0

    Proportion of antibiotics prescribed as delayed antibiotic prescriptions at index consultation (day 0).

  6. Antibiotics prescribed during follow-up

    Time frame: Up until day 28

    Proportion of participants with antibiotics prescribed within 7 and 28 days after index consultation.

  7. Re-consultations

    Time frame: 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.

  8. Admission to hospital

    Time frame: Up until day 28.

    Proportion of participants admitted to hospital within 28 days after index consultation.

  9. Complications

    Time frame: 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.

  10. Other imaging than FLUS performed

    Time frame: 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.

  11. Types of other imaging performed

    Time frame: Up until day 28.

    Types of other imaging than FLUS performed within 28 days after index consultation.

  12. Referred with suspicion of cancer

    Time frame: Up until day 60.

    Proportion of participants referred with suspicion of cancer within 60 days after index consultation.

  13. Diagnoses of cancer

    Time frame: Up until day 60.

    Proportion of participants in groups diagnosed with cancer within 60 days after index consultation.

  14. Spontaneously reported unintended events

    Time frame: Up until day 60.

    Number of spontaneously reported unintended events up until 60 days after index consultation.

  15. Mortality

    Time frame: Up until day 28 and 60.

    All-cause mortality up until day 28 and day 60.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study 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

Acronym: PLUS-FLUS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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