Status:
NOT_YET_RECRUITING
Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia
Lead Sponsor:
Meyer Children's Hospital IRCCS
Collaborating Sponsors:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Pneumonia Childhood
Pneumonia
Eligibility:
All Genders
3-10 years
Phase:
NA
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...
Detailed Description
This prospective, randomized, multicenter clinical trial aims to determine whether using lung ultrasound (LUS) in children aged 3-10 years with suspected pneumonia can reduce the prescription of antib...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
659 Patients enrolled
Trial Details
Trial ID
NCT06921993
Start Date
May 5 2025
End Date
September 30 2026
Last Update
April 10 2025
Active Locations (1)
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1
Meyer Children's Hospital IRCCS
Florence, Italy, Italy, 50139