3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT (NCT07647835) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT
Pakistan250 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
3 Months – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Clinical Cure at Day 14