A study to evaluate and compare the outcome of no antibiotic use versus immediate antibiotic use in children with uncomplicated upper respiratory tract infection- A randomised control study.

Sms medical college1 个研究点分布在 1 个国家目标入组 240 人开始时间: 2024年1月5日最近更新: 2024年3月29日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方: Sms medical college
入组人数: 240
试验地点: 1
主要终点: duration of symptoms of upper 1.respiratory tract infection as calculated to the point when symptoms disappear

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Majority of upper respiratory tract infection are of viral origin and are often self limiting. Antibiotic prescription in URTI’s are inappropriately very high.Therefore the purpose of the study is to reduce the irrational use of antibiotic in URTI’s in children in india.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, variable
盲法: Participant Blinded

入排标准

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

入选标准

•1.presenting at pediatric outdoor with signs and symptoms of upper respiratory tract infection
•duration of illness less than 3 days
•provided written consent.

排除标准

•1.diagnosis of tuberculosis, pneumonia, ARDS
•any complicated respiratory tract infection requiring admission to indoor department.
•chronic respiratory illness.
•4.reactive airway disease.

结局指标

主要结局

duration of symptoms of upper 1.respiratory tract infection as calculated to the point when symptoms disappear

时间窗: Outcome will be assessed after 48 hours, 7 days and 14 days of intervention.

2.severity of infection as assessed by scoring on a 7 point linkert scale

时间窗: Outcome will be assessed after 48 hours, 7 days and 14 days of intervention.

次要结局

1. use of antibiotics during entire coarse of illness(2. parental satisfaction assessed on a 6 point linkert scale)

研究者

发起方

Sms medical college

申办方类型

Government medical college

研究点 (1)

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