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临床试验/CTRI/2025/08/093299
CTRI/2025/08/093299尚未招募不适用

Clinico-Epidemiological Bacteriological Profile and Outcome of children with Empyema Thoracis

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年9月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
96
试验地点
1
主要终点
A)-Clinico-epidemiological profile-

研究概览

简要总结

Empyema thoracis is a collection of suppurative fluid in the pleural cavity secondary to bacterial pneumonia. It is frequently seen affecting paediatric age group, with reported incidence of 3.3 pre 100000 children. The disease can cause significant morbidity in children if adequate treatment is not given in time. Various treatment options include antibiotic alone or chest tube drainage, intrapleural fibrinolytics, video assisted thoracoscopic surgery (VATS), and open decortication. We plan to do a prospective hospital-based observational study from April 2025 to March 2029 in children between age group of 3 months to 18 years diagnosed with empyema both clinically and radiologically. We plan to determine the clinico-epidemiological and bacteriological profile of pediatric patients with empyema thoracis and to study treatment outcome of patient during their hospital stay. Relevant clinical and demographic details will be noted as per study profile. Bacteriological profile of pleural aspirate and blood culture in patients will be noted. Following outcomes will be assessed and reported in terms of duration of ICU stay, duration of hospital stay and complications during hospital stay.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Children diagnosed with empyema thoracis between age 3 months to 18 years.

排除标准

  • Case of empyema thoracis secondary to- 1) Thoracic injury 2)Bronchogenic carcinoma 3)Post surgical infections 4)Post surgical intervention Failure to obtain consent.

结局指标

主要结局

A)-Clinico-epidemiological profile-

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

1)Age

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

2)Gender

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

3)Vaccination status (PCV,HiB)

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

4)Recent history of hospitalization with pneumonia (past one month)

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

5)Recent history of Antibiotic use (past 1 month)

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

6)Clinical features like fever,cough, chest pain, respiratory distress.

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

B)Bacteriological profile-

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

1)Pleural fluid

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

2)Blood culture

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

3)Respiratoty biofire

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

4)ZN stain of pleural aspirate/tissue.

时间窗: During hospital stay of patient | (from admission up till treatment) no post discharge follow up

次要结局

  • 1)Duration of ICU stay(2)Duration of hospital stay)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Alpana Prasad

Sir Ganga Ram Hospital, Delhi

研究点 (1)

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