Antibiotic stewardship initiative: A procalcitonin based approach to guide antibiotic therapy in pediatric lower respiratory tract infection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To decide on the duration of antibiotic therapy based on Procalcitonin values.
研究概览
简要总结
This randomized controlled trial investigates the effectiveness of a procalcitonin guided approach to antibiotic therapy in children aged two months to five years admitted with lower respiratory tract infections. These infections are a major cause of hospitalization and antibiotic use in pediatric populations. Although many of these illnesses are viral, antibiotics are frequently prescribed due to the difficulty in clinically distinguishing viral from bacterial infections. This leads to unnecessary antibiotic exposure, which contributes to the growing problem of antimicrobial resistance, longer hospital stays, increased healthcare costs, and avoidable drug related adverse effects.
Procalcitonin is a biomarker that increases in bacterial infections and remains low in viral illnesses, making it a valuable tool to guide antibiotic decision making. The purpose of the study is to assess whether using procalcitonin levels to initiate and discontinue antibiotics can optimize therapy without compromising patient safety. Participants in the intervention arm receive antibiotic decisions based on predefined procalcitonin thresholds, while the control group follows standard clinical judgment.
The primary objective is to evaluate the duration of antibiotic use based on procalcitonin levels. Secondary objectives include assessing the rate of antibiotic initiation, hospital stay length, antibiotic associated adverse events, and clinical outcomes such as treatment failure, relapse, ICU transfer, and mortality. The central hypothesis is that procalcitonin guided therapy will significantly reduce unnecessary antibiotic use, minimize hospital stay, and maintain comparable or better clinical outcomes compared to standard care. Ethical approval, informed consent, and adherence to national and international guidelines ensure that the study upholds patient safety and research integrity.
This trial aims to provide strong clinical evidence supporting biomarker based antibiotic stewardship in pediatric lower respiratory tract infections, potentially informing future treatment protocols and helping address the global threat of antimicrobial resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 2 months to 5 years with clinical diagnosis of lower respiratory tract infection like pneumonia , bronchitis , bronchiolitis with or without radiological confirmation and with informed consent from parents or guardians.
排除标准
- •The exclusion criteria included neonates, children with known immunodeficiency conditions such as HIV infection, malignancy, post-transplant status, or primary immunodeficiency disorders.
- •Children with chronic lung diseases including cystic fibrosis and bronchiectasis were also excluded.
- •Patients presenting with severe sepsis, empyema, pleural effusion, or those requiring ICU admission at presentation were not included.
- •Additionally, children who had received antibiotics within the previous seven days or whose parents or guardians refused consent or withdrew consent were excluded from the study.
结局指标
主要结局
To decide on the duration of antibiotic therapy based on Procalcitonin values.
时间窗: On the day of completion of antibiotic course based Procalcitonin values which are to be measured at admission and subsequently at 48 hour interval until below the cut off value.
次要结局
- To determine the rate of antibiotic initiation based on Procalcitonin based therapy.(At the time of initial clinical assessment or hospital admission.)
- To compare the length of hospital stay between the Procalcitonin guided group and the standard care group.(At hospital discharge)
- To evaluate the incidence of antibiotic associated adverse effects in both groups.(Throughout hospitalization and at discharge or within seven days of discharge.)
- To assess clinical outcomes including treatment failure, relapse, ICU transfer, and mortality.(During hospital stay and up to 7 days post discharge.)
研究者
Ishita Diwedy
Government Multispeciality Hospital