Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections. A Randomized Controlled Trial.

NCT06876766 | Not Yet Recruiting DMC

• 1 other identifier: BIO-2024-0304
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title: Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents with Lower Respiratory Tract Infections (PLUS-AP Trial) Purpose of the Study: This study is being done to find out if a type of imaging called lung ultrasound (LUS) can help doctors decide when to stop antibiotics in children and teens who are in the hospital with lung infections, like pneumonia. Antibiotics are often given to these patients, but sometimes they are used for longer than necessary, which can be harmful. The investigators want to see if using LUS helps doctors make decisions that reduce unnecessary antibiotic use, which can help prevent antibiotic resistance and other complications. What is Lung Ultrasound (LUS)? Lung ultrasound is a safe, non-invasive, and painless test that uses sound waves to look at the lungs. It doesn't involve radiation like chest X-rays. It is already being used to help doctors understand lung conditions, and this study will test if it can also help in deciding when to stop antibiotics. How the Study Works: Participants: Children and adolescents (ages 3 months-18 years) who are admitted to the hospital with a lung infection. Groups: LUS Group: These patients will have a lung ultrasound within 24 hours of enrollment. The results will help guide decisions about when to stop antibiotics. Standard Care Group: These patients will receive regular hospital care, which may include chest X-rays and other tests to guide their treatment. What Will Be Measured? Primary Goal: The study will measure how long children and teens stay on antibiotics. The investigators are testing whether LUS can help shorten this time without affecting their recovery. Secondary Goals: Investigators will also look at how long patients stay in the hospital, whether they need further treatment or care after leaving. Why is This Important? If this study shows that LUS can safely reduce the use of antibiotics, it could change how doctors treat lung infections in children. Reducing unnecessary antibiotic use can help fight antibiotic resistance and protect children from side effects of unnecessary treatments.

Conditions

Lower Resp Tract Infection

Outcome Measures

Primary Outcomes (1)

• Antibiotic Prescription Rate Upon Discharge

  The primary outcome is the rate of antibiotic prescriptions at the time of discharge. This will compare the proportion of children and adolescents with lower respiratory tract infections (LRTIs) who are prescribed antibiotics upon discharge in the experimental group (Lung Ultrasound \[LUS\]) versus the control group (Sham Lung Ultrasound \[SLUS\]) or standard care. The aim is to assess whether the use of LUS can reduce unnecessary antibiotic prescriptions at discharge.

  Upon discharge (up to 30 days).

Study Arms (2)

Lung Ultrasound ''LUS''

EXPERIMENTAL

Participants in this group will undergo a lung ultrasound within 24 hours of enrollment. The results of this ultrasound will be used to help guide decisions about when to stop antibiotic therapy, aiming to reduce unnecessary antibiotic use.

Device: Lung Ultrasound

Sham lung ultrasound ''SLUS''

SHAM COMPARATOR

Participants in this group will receive the standard clinical care for lower respiratory tract infections, which may include diagnostic tests such as chest X-ray, with antibiotic therapy managed according to the usual clinical protocols.

Device: Sham

Interventions

Lung Ultrasound DEVICE

Lung ultrasound (LUS) is a non-invasive, radiation-free imaging technique that uses sound waves to visualize the lungs. It will be used in the experimental arm to help guide decisions regarding antibiotic therapy in hospitalized children and adolescents with lower respiratory tract infections (LRTIs). The LUS will be performed within 24 hours of enrollment.

Lung Ultrasound ''LUS''

Sham DEVICE

In the sham group, participants will undergo a mock or placebo version of the lung ultrasound. This involves performing the procedure in a way that mimics the real ultrasound process but does not provide any diagnostic results or influence clinical decision-making regarding antibiotic therapy.

Sham lung ultrasound ''SLUS''

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 3 months and 17 years old inclusive
• Currently admitted to the pediatric Ward or boarding in the Emergency Department within 24 hours of admission order due to lower respiratory tract infections.

You may not qualify if:

• Sickle cell disease (SCD).
• On chemotherapy or any other immunosuppressive therapy except systemic corticosteroids use of ≤ 5 days duration.
• Cystic fibrosis and other chronic lung diseases except asthma
• Pre-existing and/or congenital neurologic, metabolic, and cardiac conditions
• Hospitalized within the previous month
• Patients with suspected foreign body aspiration -Received antibiotic therapy within the previous week
• Patients admitted under PI's care

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03