NCT06921993: LUSCAP

Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

Recruiting now NA Last updated 3 April 2026

What this trial tests

NA trial testing LUNG ULTRASOUND in Pneumonia Childhood in 659 participants. Currently enrolling.

Timeline

24 April 2025

Primary endpoint
31 December 2027

30 June 2028

Quick facts

Lead sponsor	Meyer Children's Hospital IRCCS
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	659
Start date	24 April 2025
Primary completion	31 December 2027
Estimated completion	30 June 2028
Sites	18 locations across Italy, United States, Israel

Drugs / interventions tested

• LUNG ULTRASOUND

Conditions studied

• Pneumonia Childhood — all drugs for Pneumonia Childhood →
• Pneumonia — all drugs for Pneumonia →
• Lung Ultrasound — all drugs for Lung Ultrasound →
• Antibiotic Stewardship — all drugs for Antibiotic Stewardship →

Sponsor

Meyer Children's Hospital IRCCS

Who can join

Adults 3 to 10, any sex, with Pneumonia Childhood or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.