Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorMeyer Children's Hospital IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.

Systemic Symptoms: Fever, Hypoxia, Decreased appetite.

Disqualifiers

Neonates and children up to 3 years of age, and children older than 10 years

Recent hospitalization (within the past 14 days)

Prior CXR or any other chest imaging (e.g. CT scan)

Ongoing antibiotic therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • LUNG ULTRASOUND

    Diagnostic test

    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

Treatment groups

659 Participants
are divided into 2 treatment groups
Group A: Control group - standard of careNo intervention 0 interventions
Group B: Experimental Group - Lung Ultrasound (LUS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants with antibiotic use

A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the

Time frame
7 days

Secondary outcomes

1

Percentage of participants who had hospital admission

Chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.

Time frame
7 days
2

Percentage of participants with antibiotic use

A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the assessment.

Time frame
7 days

Other outcomes

1

Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR

Diagnostic accuracy of the 2 different imaging techniques

Time frame
30 days
2

Comparison of Unscheduled Healthcare Visits

Percentage of participants who had unscheduled healthcare visits after the index ED visit between those subjects who undergo CXR first and those who undergo LUS first.

Time frame
7 days
3

Comparison of the Length of Stay in the emergency department

Chart review conducted to assess overall length of stay in the ED.

Time frame
day 1

Sponsors and contacts

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Meyer Children's Hospital IRCCS

Lead sponsor

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

Collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborator

Gaslini Children's Hospital

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

University Hospital Padova

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

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

Collaborator

Bambino Gesù Hospital and Research Institute

Collaborator

Santobono-Pausilpon Hospital

Collaborator

Asst Degli Spedali Civili Di Brescia

Collaborator

IRCCS Burlo Garofolo

Collaborator

Clinica Pediatrica Università di Novara

Collaborator

Hospital of Prato

Collaborator

Columbia University

Collaborator

Schneider Children's Medical Center, Israel

Collaborator

Yale University

Collaborator

University of Melbourne

Collaborator