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临床试验/NCT06532409
NCT06532409尚未招募不适用

Efficacy of Oral Amoxicillin in Comparison to Intravenous Ceftriaxone in Treatment of Uncomplicated Community Acquired Pneumonia (Cap) Among Children of Age 2-5 Years of Age

RESnTEC, Institute of Research1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
试验地点
1
主要终点
Free from fever

研究概览

简要总结

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

详细描述

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of both gender
  • Aged from 2 to 5 years
  • With fever >37.5 C (99.5 F)
  • Will be presented with symptoms and signs of uncomplicated community acquired pneumonia

排除标准

  • Children requiring ICU care (having cyanosis SpO2 < 85% requiring intubation within first day of admission or in state of shock)
  • Children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency
  • Children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation
  • Children already on antibiotics
  • Presence of any complication of community acquired pneumonia
  • Patients having symptoms of multi-organ involvement/sepsis
  • Hypersensitivity to Amoxicillin or Ceftriaxone
  • Other co-existing infections like dengue, malaria, or measles

研究组 & 干预措施

Oral Amoxicillin

Experimental

Patients in this group will receive IV amoxicillin/CA at a dose of 100 mg per kg per day in 3 divided doses for a maximum period of 7 days.

干预措施: Amoxicillin/CA (Drug)

IV Ceftriaxone

Experimental

Patients in this group will receive IV ceftriaxone at a dose of 75 mg per kg per day in 2 divided doses for a maximum period of 7 days.

干预措施: IV ceftriaxone (Drug)

结局指标

主要结局

Free from fever

时间窗: 3 days

Efficacy will be labeled yes where fever symptoms are resolved (temperature = 98.6ºF) within 3 days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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