Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07647835

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

Conditions: Community Acquired Pneumonia, Childhood Pneumonia

Sex: All
Ages: 3 Months – 5 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 250
Sponsor: Khyber Teaching Hospital

Location: Khyber Teaching Hospital Peshawar Khyber Pakhtunkhwa

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.

Eligibility Criteria

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07647835). StuddyBuddy aggregates publicly available trial information.