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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.

調査の概要

状態

まだ募集していません

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

250

段階

  • 初期フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Khyber Pakhtunkhwa
      • Peshawar、Khyber Pakhtunkhwa、パキスタン、25000
        • Khyber Teaching Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:- 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
実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants with Clinical Cure at Day 14
時間枠: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:
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月15日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Amoxicillinの臨床試験

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