6/29/23, 1:12 AM RETAPP Pathway Feedback Search Clinical Topics Home Studies RETAPP RETAPP Disease Community-acquired pneumonia Trial question Is placebo noninferior to amoxicillin among children younger than 5 years of age with nonsevere pneumonia and tachypnea? Study design Multi-center Double blinded RCT Population Characteristics of study participants 47.0% female N = 4002 53.0% male 4002 patients (1899 female, 2103 male) Inclusion criteria: children aged 2 to 59 months in a resource-limited primary healthcare setting who met WHO criteria of nonsevere pneumonia with tachypnea Key exclusion criteria: pedal edema, history of hospitalization in last two weeks, severe lower chest wall in-drawing, asthma, tuberculosis or other severe illness, antibiotics use in last 48 hours Interventions N=1999 a test regimen (matched volume of placebo for 3 days) N=2003 an active control (50 mg/mL suspension of amoxicillin for 3 days) Primary outcome https://web.pathway.md/studies/rec2y5fJFDJqO7S9G 1/2 6/29/23, 1:12 AM RETAPP Pathway Rate of treatment failure by day 3 4.9 % 4.9 3.7 % 2.6 2.5 % Difference exceeding nonferiority margin 1.2 % 0.0 % A test regimen An active control Difference exceeding nonferiority margin in the rate of treatment failure by day 3 (4.9% vs. 2.6%; AD 2.3%, 95% CI 0.9 to 3.7) Secondary outcomes No significant difference in the rate of relapse between day 4-14 (2.2% vs. 3.1%; AD -0.91%, 95% CI -2.08 to 0.27) Significant increase in fever (8% vs. 3.9%; AD 4.08%, 95% CI 1.48 to 6.68) Significant increase in wheeze (10.1% vs. 3.1%; AD 7.01%, 95% CI 1.35 to 12.67) Safety outcomes No significant difference in adverse events. Conclusion In children aged 2 to 59 months in a resource-limited primary healthcare setting who met WHO criteria of nonsevere pneumonia with tachypnea, a test regimen was not noninferior to an active control with respect to the rate of treatment failure by day 3. Reference Fyezah Jehan, Imran Nisar, Salima Kerai et al. Randomized Trial of Amoxicillin for Pneumonia in Pakistan. N Engl J Med. 2020 Jul 2;383(1):24-34. Open reference URL https://web.pathway.md/studies/rec2y5fJFDJqO7S9G 2/2