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临床试验/NCT06977971
NCT06977971已完成不适用

Evaluation of Clinical, Laboratory, and Radiologic Parameters Affecting Antibiotic Use and Associated Cost in RSV-Positive Children With Acute Lower Respiratory Tract Infections

Dr. Behcet Uz Children's Hospital1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2017年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
209
试验地点
1
主要终点
Association between clinical/laboratory/radiologic parameters and antibiotic prescription

研究概览

简要总结

This study retrospectively evaluated the clinical, laboratory, and radiologic factors that influence the decision to prescribe antibiotics in children under 2 years of age hospitalized with RSV-positive acute lower respiratory tract infections. The study also examined the economic impact of antibiotic use in these patients. The goal is to improve clinical decision-making and reduce unnecessary antibiotic exposure in children with viral infections.

详细描述

This retrospective, single-center study aimed to assess the clinical decision-making process regarding antibiotic prescription in children aged 1 to 24 months hospitalized with RSV-positive acute lower respiratory tract infections (ALRTI). The study was conducted at Dr. Behçet Uz Children's Hospital and covered four consecutive RSV seasons (April 2017 - April 2021). RSV infection was confirmed via multiplex PCR.

Clinical and laboratory variables potentially influencing antibiotic use included fever, respiratory distress, CRP levels, leukocyte count, and radiologic findings such as infiltrates on chest X-ray. The study also examined whether antibiotic selection (agent, timing, and duration) was associated with specific clinical profiles or severity indicators.

Hospitalization cost data were analyzed to estimate the economic burden of antibiotic use in RSV-positive patients. The study contributes to improved antimicrobial stewardship by identifying patterns of potentially unnecessary antibiotic prescriptions in viral respiratory infections.

Ethical approval was obtained from the local ethics committee (Approval No: 2021-634), and the study adhered to the principles of the Declaration of Helsinki.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 1 and 24 months at the time of hospitalization
  • Laboratory-confirmed RSV positivity via multiplex PCR
  • Hospitalized for acute lower respiratory tract infection
  • Complete hospitalization and clinical data available

排除标准

  • Detection of additional respiratory pathogens on multiplex PCR
  • Discharge against medical advice before treatment was completed
  • Missing or incomplete key clinical, laboratory, or radiologic data
  • ICU admission without full follow-up data

结局指标

主要结局

Association between clinical/laboratory/radiologic parameters and antibiotic prescription

时间窗: During hospitalization (April 2017 - April 2021)

This outcome assesses the relationship between objective findings (e.g., CRP levels, abnormal chest X-ray, fever) and the decision to initiate antibiotic therapy in RSV-positive children aged 1-24 months hospitalized with acute lower respiratory tract infections.

次要结局

  • Total antibiotic-related hospitalization cost per patient(During hospitalization (April 2017 - April 2021))

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu Busra Acar

Pediatric Cardiology Fellow, Ege University Faculty of Medicine

Dr. Behcet Uz Children's Hospital

研究点 (1)

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