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临床试验/CTRI/2025/11/097393
CTRI/2025/11/097393尚未招募4 期

Intrapleural streptokinase adjunct to conventional treatment vs conventional treatment in paediatric empyema-An open labelled randomized control trial.

Shubham Rastogi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This randomized open label controlled trial aims to evaluate the efficacy and safety of intrapleural streptokinase as an adjunct to conventional management in children with empyema . Participants aged 2 - 18 years with confirmed diagnosis of empyema will be randomized into two groups : one receiving conventional treatment alone while the other receiving intrapleural streptokinase in addition to conventional treatment . The primary outcome will be improved in clinical condition and radiological resolution , while secondary outcomes will include duration of hospital stay , need for surgical intervention and adverse effects . The study will be conducted in department of paediatrics at  kalawati saran children’s hospital.

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 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients with definitive diagnosis of empyema with visible puson diagnostic pleural tap and/or septations /loculations on ultrasound of chest.

排除标准

  • Any history of coagulopathy b.
  • Confirmed case of pneumothorax or bronchopleural fistula c.
  • Any history of head trauma in preceeding 2 weeks .
  • Any history of recent major surgery .

研究者

发起方
Shubham Rastogi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shubham Rastogi

Lady hardinge medical college

研究点 (1)

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