Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
ID06921993

Lung Ultrasound for Antibiotic Stewardship in Community-Acquired Pneumonia: A Randomized Clinical Trial

Led by Meyer Children's Hospital IRCCS · Updated on 2026-04-03

659

Participants Needed

18

Research Sites

26 weeks

Total Duration

On this page

Sponsors

M

Meyer Children's Hospital IRCCS

Lead Sponsor

F

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pneumonia is a leading cause of illness and death among children under five years old, often requiring hospitalization. Diagnosing pneumonia is difficult due to the lack of a universally accepted standard, with current guidelines relying on history and physical exam that cannot reliably distinguish pneumonia from other respiratory infections or identify bacterial versus viral causes. This uncertainty can lead to unnecessary antibiotic use. Lung ultrasound has shown promise in diagnosing pneumonia with high sensitivity and specificity but cannot reliably differentiate bacterial from viral causes and may lead to increased antibiotic use due to detection of minor lung changes. This trial aims to evaluate whether lung ultrasound can reduce antibiotic prescriptions in children with suspected pneumonia compared to standard care. Children aged 3 to 10 years presenting with signs of lower respiratory tract infection and stable clinical status are randomized to either a lung ultrasound group or a standard care group. In the lung ultrasound group, ultrasound is performed immediately after clinical assessment, while the control group receives standard care based on clinical evaluation with optional chest X-ray and blood tests if needed. Clinicians may request chest X-rays in both groups as appropriate, and antibiotic decisions remain at the treating physician's discretion. The study also compares how often lung ultrasound influences clinical decisions and its diagnostic accuracy compared to traditional methods. Participants undergo routine evaluations including history, physical exam, and lung ultrasound if assigned. Data on pneumonia likelihood and antibiotic prescription willingness are collected at multiple decision points using rating scales. Follow-up includes a call 5 to 7 days after discharge to monitor progress and antibiotic use. Outcomes measured include antibiotic use within 7 days, hospital admissions, emergency department stay length, and unscheduled healthcare visits. An expert panel reviews clinical data for final diagnosis. Data are securely recorded with patient privacy maintained. The study aims to clarify if lung ultrasound can improve pediatric pneumonia management and reduce unnecessary antibiotic use without compromising care.

CONDITIONS

Brief Title

Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

Who Can Participate

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Well-appearing, clinically stable children aged 3 to 10 years
  • Presenting with signs and symptoms of lower respiratory tract infection such as cough, fast breathing, fever, or abnormal lung sounds
  • Suspected pneumonia based on clinical evaluation
Not Eligible

You will not qualify if you...

  • Children younger than 3 years or older than 10 years
  • Hospitalization within the past 14 days
  • Prior chest imaging such as X-ray or CT scan
  • Ongoing antibiotic therapy
  • Severe respiratory distress or hemodynamic instability
  • History of aspiration pneumonia
  • Underlying conditions increasing risk for severe or recurrent pneumonia, including immunodeficiency, chronic corticosteroid use, chronic lung disease, cancer, sickle cell disease, congenital heart disease, tracheostomy, or neuromuscular respiratory disorders
  • Respiratory failure requiring urgent emergency assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of enrollment

Participants undergo clinical assessment with or without lung ultrasound (LUS) depending on group assignment to evaluate suspected pneumonia.

1 visit (in-person) on the day of enrollment

Monitoring

Duration - 5 to 7 days

Participants are observed for clinical progress and antibiotic use following initial assessment.

1 follow-up call 5 to 7 days post-discharge

Trial Site Locations

Total: 18 locations

1

Rady Childrens/UCSD

San Diego, California, United States, 92123

Active, Not Recruiting

2

Yale New Haven Children's Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

3

Columbia University

New York, New York, United States, 10027

Not Yet Recruiting

4

University of Wisconsin

Madison, Wisconsin, United States, 53706

Active, Not Recruiting

5

Schneider Children's Hospital

Petah Tikva, Israel, 49202

Not Yet Recruiting

6

Meyer Children's Hospital IRCCS

Florence, Italy, Italy, 50139

Actively Recruiting

7

ASST Papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

8

IRCCS Sant'Orsola

Bologna, Italy

Actively Recruiting

9

Ospedale dei Bambini

Brescia, Italy

Not Yet Recruiting

10

IRCCS Istituto Giannina Gaslini

Genova, Italy

Actively Recruiting

11

IRCCS Fondazione Cà Granda - Policlinico

Milan, Italy

Active, Not Recruiting

12

Ospedale Pediatrico Santobono - Pausillipon

Naples, Italy

Not Yet Recruiting

13

Ospedale Maggiore della Carità

Novara, Italy

Actively Recruiting

14

Azienda Ospedale Università di Padova

Padova, Italy

Actively Recruiting

15

IRCCS Gemelli

Roma, Italy

Active, Not Recruiting

16

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Not Yet Recruiting

17

Ospedale Infantile Regina Margherita

Torino, Italy

Not Yet Recruiting

18

Ospedale Burlo Garofolo

Trieste, Italy

Not Yet Recruiting

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Research Team

N

Niccolò Parri, MD

M

Martina Cecchetti, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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