Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Antibiotic Prescription Rate Upon Discharge
研究概览
简要总结
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.
详细描述
The PLUS-AP Trial (Pediatric Lung Ultrasound to Guide Antibiotic Prescriptions for Hospitalized Children and Adolescents with Lower Respiratory Tract Infections) is a randomized controlled trial designed to assess the effect of pediatric lung ultrasound (LUS) on antibiotic prescribing practices for children and adolescents hospitalized with lower respiratory tract infections (LRTIs). This study aims to explore whether incorporating LUS into clinical decision-making can reduce the unnecessary use of antibiotics without compromising patient care.
Background:
Antibiotics are frequently overprescribed for LRTIs in pediatric populations, contributing to antibiotic resistance and unnecessary adverse events. While chest X-rays are commonly used to diagnose LRTIs, they can be resource-intensive and involve radiation exposure. Lung ultrasound (LUS) is a non-invasive, radiation-free imaging modality that has gained recognition for its utility in diagnosing and monitoring respiratory diseases. This trial will evaluate whether LUS can assist clinicians in making more accurate diagnostic decisions and potentially reduce the use of antibiotics in hospitalized pediatric patients with LRTIs.
Study Objectives:
Primary Objective: To assess whether the use of pediatric lung ultrasound (LUS) reduces the duration of antibiotic treatment in hospitalized children and adolescents diagnosed with LRTIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Sham lung ultrasound ''SLUS''
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.
干预措施: Sham (Device)
Lung Ultrasound ''LUS''
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.
干预措施: Lung Ultrasound (Device)
结局指标
主要结局
Antibiotic Prescription Rate Upon Discharge
时间窗: Upon discharge (up to 30 days).
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.
次要结局
未报告次要终点