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

NCT07647835 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 318/IREB/KTH
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Community Acquired Pneumonia; Childhood Pneumonia

Keywords

Amoxcillin in childhood pneumonia; community acquired pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

  14 days

• 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

  5 days

Study Arms (2)

- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.

ACTIVE COMPARATOR

\- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.

Drug: Amoxicillin

Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days

EXPERIMENTAL

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

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Giving drug for 3 days instead of 5 days

- Group B (5-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 5 days.; Group A (3-day): Amoxicillin suspension 80-90 mg/kg/day divided twice daily for 3 days

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• months to 1 years ≥ 50 breaths per minute
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Zia Muhammad, MBBS FCPS CHPE CHR PGPN

CONTACT

+923315500086; drziamuhammad@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Computer-generated randomization sequence with block sizes of 4, 6, and 8. Allocation concealment through sequentially numbered, opaque, sealed envelopes maintained by hospital pharmacy. Stratification by age group (3-11 months vs. 12-59 months).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and supervisor Department Of Child Health Khyber Teaching Hospital Peshawar

Model Details: PROBE (Prospective randomized open label blinded endpoint) single-blind, randomized controlled trial.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

PA (1)