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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-5
SponsorKhyber Teaching Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin

    Drug

    Giving drug for 3 days instead of 5 days

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: - Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.Active comparator 1 intervention
Group B: Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 daysExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Clinical Cure at Day 14

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

Time frame
14 days
2

Number of Participants withTreatment Failure:

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

Time frame
5 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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