Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

NCT06921993 | Not Yet Recruiting

• 1 other identifier: LUSCAP
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pneumonia; Children; Pediatrics; Lung ultrasound; point-of-care ultrasound

Outcome Measures

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

  7 days

Secondary Outcomes (2)

• Percentage of participants who had hospital admission

  7 days

• Percentage of participants with antibiotic use

  7 days

Other Outcomes (3)

• Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR

  30 days

• Comparison of Unscheduled Healthcare Visits

  7 days

• Comparison of the Length of Stay in the emergency department

  day 1

Study Arms (2)

Control group - standard of care

NO INTERVENTION

All subjects randomly assigned to the control arm will undergo a complete patient history and clinical assessment (the reference standard). If there is clinical uncertainty, the enrolling physician has the option to perform other test such as CXR or blood test.

Experimental Group - Lung Ultrasound (LUS)

EXPERIMENTAL

All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . The LUS will be performed immediately following a thorough patient history and complete clinical assessment. 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

Diagnostic Test: LUNG ULTRASOUND

Interventions

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

Experimental Group - Lung Ultrasound (LUS)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:
• Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
• Systemic Symptoms: Fever, Hypoxia, Decreased appetite.

You may not qualify if:

• Neonates and children up to 3 years of age, and children older than 10 years
• Children aged 3 to 10 years with any of the following factors:
• Recent hospitalization (within the past 14 days)
• Prior CXR or any other chest imaging (e.g. CT scan)
• Ongoing antibiotic therapy
• Hemodynamic instability
• Respiratory failure or severe respiratory distress and/or hypoxemia, requiring urgent assessment for conditions such as pneumothorax, hemothorax, or other emergency respiratory conditions
• History of aspiration or ab ingestis pneumonia
• Underlying medical conditions predisposing to severe or recurrent pneumonia, including immunodeficiency, chronic corticosteroid use, chronic lung disease, malignancy, sickle cell disease, congenital heart disease, tracheostomy, and neuromuscular disorders affecting respiration

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead
• 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

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Italy, 50139, Italy

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Niccolò Parri, MD

  Meyer Children's Hospital IRCCS, Florence, Italy

  STUDY DIRECTOR

Central Study Contacts

Niccolò Parri, MD

CONTACT

+390555662320/2634; niccolo.parri@meyer.it

Martina Cecchetti, MD

CONTACT

luscaptrial@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized diagnostic clinical trial

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 10, 2025
• Study Start: May 5, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)