Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
NCT06921993

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

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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