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3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT (Pnemonia)

2026年6月9日 更新者:Zia Muhammad、Khyber Teaching Hospital

Comparison 0f 03days Vs 05days Amoxicillin In Uncomplicated Community Acquired Pneumonia In Children. A Randomized Controlled Trial

Pneumonia is the most common infection in children and leading to most common cause of mortality and morbidity in in children globally. Bacterial cause is mostly streptococcus pneumonia in children of 3 months to 5 years of age. Traditionally 7-10 antibiotic is used for uncomplicated community acquired pneumonia. World health organization (WHO) recommends 5 days of antibiotic for non-severe pneumonia with oral amoxicillin while National institute for health and care excellence (NICE) guidelines 2025 recommends 3-days course of amoxicillin in uncomplicated community acquired pneumonia.1,2 Most studies show Short course antibiotic is as effective as long course of antibiotic with fewer side effect. The Khyber Pakhtunkhwa province faces particular challenges due to limited healthcare access, malnutrition, and suboptimal vaccination coverage which leads to major burden of pneumonia in less than 5 years' children.7 There is need of local data about effectiveness of short course antibiotic in uncomplicated community acquired pneumonia. 3-day oral amoxicillin has better compliance and less side effect of medicine. Short course of oral amoxicillin is cost effective as pneumonia is more common in low socioeconomic population and 3-day course antibiotic is more economical and has better compliance. Long course of antibiotic leads to antibiotic resistance and adverse effects like diarrhea and other gastrointestinal symptoms.

研究概览

地位

尚未招聘

详细说明

Pneumonia is the most common infection in children and leading to most common cause of mortality and morbidity in in children globally. Bacterial cause is mostly streptococcus pneumonia in children of 3 months to 5 years of age. Traditionally 7-10 antibiotic is used for uncomplicated community acquired pneumonia. World health organization (WHO) recommends 5 days of antibiotic for non-severe pneumonia with oral amoxicillin while National institute for health and care excellence (NICE) guidelines 2025 recommends 3-days course of amoxicillin in uncomplicated community acquired pneumonia.1,2 Most studies show Short course antibiotic is as effective as long course of antibiotic with fewer side effect. The SAFARI trial demonstrated non-inferiority of 5-day versus 10-day amoxicillin therapy in children with Community acquired pneumonia, with comparable clinical cure rates and reduced antibiotic exposure.3 Similarly, a systematic review and meta-analysis by Pernica et al. found that short-course antibiotic therapy (≤5 days) was associated with similar clinical success rates compared to longer courses in pediatric respiratory infections.4 Mortality due to childhood pneumonia is strongly linked to poverty-related factors such as undernutrition, lack of safe drinking water and sanitation, indoor and outdoor air pollution as well as inadequate access to health care.

Pneumonia kills more children than any other infectious disease, claiming the lives of over 700,000 children under 5 every year, or around 2,000 every day. This includes around 190,000 newborns. Almost all of these deaths are preventable. Globally, there are over 1,400 cases of pneumonia per 100,000 children, or 1 case per 71 children every year, with the greatest incidence occurring in South Asia (2,500 cases per 100,000 children) and West and Central Africa (1,620 cases per 100,000 children).5 No disease kills more children aged less than five years than pneumonia, not least in Pakistan where one-fifth of the population is in this age group. The annual incidence of ARI (acute respiratory infection) in Pakistani children aged less than five years is 4% in the community a group constituting roughly 22% of the country's population of 160 million. Taking this 4% figure, we can calculate that there are 15 million episodes of ARI every year among under-fives.6 The Khyber Pakhtunkhwa province faces particular challenges due to limited healthcare access, malnutrition, and suboptimal vaccination coverage which leads to major burden of pneumonia in less than 5 years' children.7 There is need of local data about effectiveness of short course antibiotic in uncomplicated community acquired pneumonia. 3-day oral amoxicillin has better compliance and less side effect of medicine. Short course of oral amoxicillin is cost effective as pneumonia is more common in low socioeconomic population and 3-day course antibiotic is more economical and has better compliance. Long course of antibiotic leads to antibiotic resistance and adverse effects like diarrhea and other gastrointestinal symptoms.

研究类型

介入性

注册 (估计的)

250

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Khyber Pakhtunkhwa
      • Peshawar、Khyber Pakhtunkhwa、巴基斯坦、25000

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion criteria:

  • Age; ≥ 3 months to 5 years
  • Fever; recorded temperature of ≥100.4 f or guardian reported fever within 2 days
  • Cough; observed or reported within 3 days
  • Tachypnea;
  • 3 months to 1 years ≥ 50 breaths per minute
  • 1 years to 5 years ≥ 40 breaths per minute
  • C- reactive protein ≥ 40
  • White blood cells ≥ 12200
  • Chest X-ray;
  • Presence of a dense opacity occupying a portion or whole of lobe with or without air Broncho grams.

Exclusion criteria:

  • Patient who is Lethargic and unable to tolerate orally.
  • Capillary refill greater than 2 second
  • Chronic lung disease
  • Congenital heart disease or sickle cell anemia patient
  • Immunocompromised patient
  • malnourished
  • Known or suspected tuberculosis patient
  • Patient has used prior antibiotic within 2 days
  • Allergic to penicillin or amoxicillin
  • C-reactive protein greater than 72
  • White blood cells greater than 25000
  • Chest x rays show linear or patchy or peri bronchial opacity
  • Presence of pleural effusions
  • Empyema, lung abscess, necrotizing pneumonia or pneumatocele
  • Other alternative diagnosis like wheezing syndrome (Bilateral wheezing on auscultation)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.
Giving drug for 3 days instead of 5 days
实验性的:Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days
Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days, followed by matched placebo for days 4-5
Giving drug for 3 days instead of 5 days

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants with Clinical Cure at Day 14
大体时间:14 days

Participants who

  • are afebrile for at least 48 hours (temperature <38°C)
  • have normal respiratory rate for age
  • have no chest indrawing or nasal flaring
  • return to normal feeding and activity level
  • do not require additional antibiotics
14 days
Number of Participants withTreatment Failure:
大体时间:5 days

Participants who

  • have persistence of fever or tachypnea at Day 5
  • develop chest indrawing, hypoxemia (SpO2 <92%), or danger signs (drowsiness, i-nability to drink, convulsions)
  • need hospitalization or intravenous antibiotics
  • require second-line antibiotic therapy
  • expire
5 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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