RecruitingNot ApplicableNCT06921993

Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

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


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

659 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 10 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

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Interventions

DIAGNOSTIC_TESTLUNG 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


Locations(18)

Rady Childrens/UCSD

San Diego, California, United States

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Columbia University

New York, New York, United States

University of Wisconsin

Madison, Wisconsin, United States

Schneider Children's Hospital

Petah Tikva, Israel

Meyer Children's Hospital IRCCS

Florence, Italy, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

IRCCS Sant'Orsola

Bologna, Italy

Ospedale dei Bambini

Brescia, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

IRCCS Fondazione Cà Granda - Policlinico

Milan, Italy

Ospedale Pediatrico Santobono - Pausillipon

Naples, Italy

Ospedale Maggiore della Carità

Novara, Italy

Azienda Ospedale Università di Padova

Padova, Italy

IRCCS Gemelli

Roma, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Ospedale Infantile Regina Margherita

Torino, Italy

Ospedale Burlo Garofolo

Trieste, Italy

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NCT06921993


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