Actively Recruiting
Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia
Led by Meyer Children's Hospital IRCCS · Updated on 2026-04-03
659
Participants Needed
18
Research Sites
166 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 major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Current guidelines recommend diagnosis based on history and physical examination, which do not reliably differentiate pneumonia from other respiratory infections or identify whether it is bacterial or viral in nature. This uncertainty can lead to the unnecessary use of antibiotics. Commonly used chest X-rays have limitations such as low sensitivity, moderate interobserver reliability, and the inability to distinguish bacterial from viral pneumonia. In contrast, lung ultrasound has shown high sensitivity and specificity for diagnosing pneumonia in children. However, lung ultrasound also cannot reliably distinguish between bacterial and viral causes and might lead to increased antibiotic prescriptions by detecting minor lung consolidations not seen on chest X-rays. Despite these issues, lung ultrasound is widely used in pediatric pulmonary assessment. The primary objective of the study is to determine if using lung ultrasound for diagnosing pneumonia in children can reduce antibiotic prescriptions compared to the standard care approach-which mainly relies on clinical diagnosis (often supplemented by chest X-ray and blood tests in selected cases). The secondary objective is to assess how frequently lung ultrasound impacts management decisions during a single clinical visit, beyond the information provided by history and physical examination. The third objective is to compare the diagnostic accuracy of lung ultrasound-supported diagnosis with existing diagnostic methods. The study hypothesizes that lung ultrasound results can act as a decision modifier, similar to other clinical tools and examination findings. However, a lack of consensus on specific lung ultrasound parameters and their clinical correlations contributes to variability in managing suspected pneumonia, potentially leading to antibiotic overuse. Eligible participants are children aged three to ten years who are in good general condition and clinically stable, presenting with signs and symptoms of lower respiratory tract infection indicative of pneumonia. Exclusion criteria include children outside the specified age range, those recently hospitalized, those who have undergone prior chest imaging, those already on antibiotic therapy, those with severe clinical instability, and those with underlying conditions predisposing them to severe or recurrent pneumonia. These criteria help ensure that the study population represents general pediatric community-acquired pneumonia cases, avoiding biases from high-risk patients. The ultimate goal of this study is to provide evidence on whether lung ultrasound can serve as a reliable tool to guide antibiotic prescriptions, thereby reducing unnecessary antibiotic use in the management of pediatric pneumonia.
CONDITIONS
Official Title
Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 10 years who are clinically stable and appear well
- Presenting with signs and symptoms of lower respiratory tract infection such as cough, fast breathing, difficulty breathing, or abnormal lung sounds
- May have systemic symptoms like fever, low oxygen levels, or decreased appetite
You will not qualify if you...
- Children younger than 3 years or older than 10 years
- Hospitalized within the past 14 days
- Prior chest imaging including X-rays or CT scans
- Currently receiving antibiotic treatment
- Severe respiratory distress, respiratory failure, or low oxygen requiring urgent emergency assessment
- History of aspiration pneumonia
- Underlying conditions that increase risk for severe or recurrent pneumonia, including immune deficiency, chronic corticosteroid use, chronic lung disease, cancer, sickle cell disease, congenital heart disease, tracheostomy, or neuromuscular disorders affecting breathing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Martina Cecchetti, MD
CONTACT
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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