Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

Summary

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

• Pneumonia Childhood
• Pneumonia
• Lung Ultrasound
• Antibiotic Stewardship

Interventions

DIAGNOSTIC_TEST

LUNG ULTRASOUND

All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol

Sponsors & Collaborators

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

  collaborator OTHER_GOV

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Gaslini Children's Hospital

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• University Hospital Padova

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Università degli Studi 'G. d'Annunzio' Chieti e Pescara

  collaborator OTHER

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• Santobono-Pausilpon Hospital

  collaborator UNKNOWN

• Asst Degli Spedali Civili Di Brescia

  collaborator OTHER

• IRCCS Burlo Garofolo

  collaborator OTHER

• Clinica Pediatrica Università di Novara

  collaborator UNKNOWN

• Hospital of Prato

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Schneider Children's Medical Center, Israel

  collaborator OTHER

• Yale University

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Meyer Children's Hospital IRCCS

  lead OTHER

Principal Investigators

• Niccolò Parri, MD · Meyer Children's Hospital IRCCS, Florence, Italy

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-24

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• United States
• Israel
• Italy

Study Locations