Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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