Lung ultrasound to guide antibiotic decisions in children with pneumonia

Lung Ultrasound for Antibiotic Stewardship in Community-Acquired Pneumonia: A Randomized Clinical Trial

This will see if using lung ultrasound for children aged 3–10 with suspected pneumonia leads to fewer antibiotic prescriptions than usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 659 (estimated)
• Ages: 3 Years to 10 Years
• Sex: All
• Sponsor: Meyer Children's Hospital IRCCS (other)
• Locations: 18 sites (San Diego, California and 17 other locations)
• Trial ID: NCT06921993 on ClinicalTrials.gov

What this trial studies

This prospective, randomized multicenter trial enrolls clinically stable children aged 3–10 who present with signs of lower respiratory tract infection and randomizes them to immediate lung ultrasound (LUS) after clinical assessment versus standard care. Clinicians in both arms may still order chest X-rays or blood tests as needed, and all treatment decisions remain at the treating physician’s discretion. The primary outcome is whether LUS reduces antibiotic prescriptions; secondary aims measure how often LUS changes decisions and compare diagnostic accuracy to current pathways. Enrollment excludes children with recent hospitalization, prior chest imaging, ongoing antibiotics, severe respiratory distress, or conditions that predispose to complicated pneumonia.

Who should consider this trial

Good fit: Children aged 3–10 who are clinically stable in the ED with symptoms of lower respiratory infection and who have not recently been hospitalized or started antibiotics are ideal candidates.

Not a fit: Children who are very ill, already on antibiotics, recently imaged, or with conditions that increase risk for complicated pneumonia are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, using LUS could reduce unnecessary antibiotic use, lowering side effects and antibiotic resistance without compromising care.

How similar studies have performed: Previous studies show lung ultrasound has high sensitivity and specificity for detecting pediatric pneumonia, but its effectiveness for reducing antibiotic prescribing is not yet well established.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
  2. Systemic Symptoms: Fever, Hypoxia, Decreased appetite.

     Exclusion Criteria:
* 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:

  1. Recent hospitalization (within the past 14 days)
  2. Prior CXR or any other chest imaging (e.g. CT scan)
  3. Ongoing antibiotic therapy
  4. Hemodynamic instability
  5. Respiratory failure or severe respiratory distress and/or hypoxemia, requiring urgent assessment for conditions such as pneumothorax, hemothorax, or other emergency respiratory conditions
  6. History of aspiration or ab ingestis pneumonia
  7. 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

Where this trial is running

San Diego, California and 17 other locations

• Rady Childrens/UCSD — San Diego, California, United States (ACTIVE_NOT_RECRUITING)
• Yale New Haven Children's Hospital — New Haven, Connecticut, United States (RECRUITING)
• Columbia University — New York, New York, United States (NOT_YET_RECRUITING)
• University of Wisconsin — Madison, Wisconsin, United States (ACTIVE_NOT_RECRUITING)
• Schneider Children's Hospital — Petah Tikva, Israel (NOT_YET_RECRUITING)
• Meyer Children's Hospital IRCCS — Florence, Italy, Italy (RECRUITING)
• ASST Papa Giovanni XXIII — Bergamo, Italy (RECRUITING)
• IRCCS Sant'Orsola — Bologna, Italy (RECRUITING)
• Ospedale dei Bambini — Brescia, Italy (NOT_YET_RECRUITING)
• IRCCS Istituto Giannina Gaslini — Genova, Italy (RECRUITING)
• IRCCS Fondazione Cà Granda - Policlinico — Milan, Italy (ACTIVE_NOT_RECRUITING)
• Ospedale Pediatrico Santobono - Pausillipon — Naples, Italy (NOT_YET_RECRUITING)
• Ospedale Maggiore della Carità — Novara, Italy (RECRUITING)
• Azienda Ospedale Università di Padova — Padova, Italy (RECRUITING)
• IRCCS Gemelli — Roma, Italy (ACTIVE_NOT_RECRUITING)
• Ospedale Pediatrico Bambino Gesù — Roma, Italy (NOT_YET_RECRUITING)
• Ospedale Infantile Regina Margherita — Torino, Italy (NOT_YET_RECRUITING)
• Ospedale Burlo Garofolo — Trieste, Italy (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Niccolò Parri, MD

Conditions: Pneumonia Childhood, Pneumonia, Lung Ultrasound, Antibiotic Stewardship, Children, Pediatrics, Lung ultrasound, point-of-care ultrasound