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临床试验/CTRI/2025/12/098381
CTRI/2025/12/098381尚未招募不适用

Multiplex respiratory PCR and serum procalcitonin based diagnostic algorithm to reduce antibiotic usage in critically ill children admitted with pneumonia

RUAS seed grant1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年12月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
124
试验地点
1

研究概览

简要总结

Children admitted to PICU with a diagnosis of pneumonia or lower respiratory tract infection requiring oxygen or higher respiratory support and meet and the inclusion and exclusion criteria will be included after informed consent. Demographic data, clinical features and treatment received collected. Nasopharyngeal swab for respiratory using Multiplex PCR ans serum procalcitonin will be sent. Antibiotics will be stopped if no bacteria is detected and PCT is negative. Child will be monitored clinical and using Point of care ultrasound for any worsening symptoms. The control group will include historic cohort of previous year managed as per existing protocol. The change in antibiotics in historic cohort based on clinical decision, chest radiograph and inflammatory markers like CRP and total leukocyte counts will be compared with study group where antibiotic decisions are based on respiratory PCR and PCT reports.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of pneumonia or lower respiratory tract infection
  • Requiring oxygen or higher respiratory support
  • Started antibiotic at admission.

排除标准

  • Children who were treated with oral or intravenous antibiotics for more than 2 days prior to admission
  • Lobar consolidation or empyema
  • Acute exacerbation of asthma
  • Co-morbid illness like severe acute malnutrition
  • Known immunodeficiency status like HIV, primary immunodeficiency, long term steroid use
  • Chronic respiratory diseases like cystic fibrosis, bronchiectasis
  • Chest wall or spine deformities
  • Congenital heart diseases
  • Fluid refractory shock.

研究者

发起方
RUAS seed grant
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Namita Ravikumar

Ramaiah Medical College

研究点 (1)

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