Title : Praziquantel for the treatment of preschool-aged children with schistosomiasis: Results of an RCT
Abstract:
Background: Optimal dosing of praziquantel for schistosomiasis for children younger than 5 years is not established and some studies suggest this age group might need a higher dosing per kilogram. Our aim was to assess the safety and efficacy of 80 mg/kg of praziquantel tablets given in a single day to preschool children versus the recommended single dose of 40 mg/kg for treatment of Schistosoma mansoni.
Methods: We conducted a 2 × 2 factorial design, placebo-controlled, phase 2 randomized trial in Uganda (ClinicalTrials.gov NCT03640377). Children aged 12–47 months infected with S. mansoni were randomly assigned in a 1:1:1:1 ratio to receive crushed praziquantel tablets at 40 mg/kg versus 80 mg/kg at baseline and either the same dose or placebo after 6 months.
Results: Among 354 children included for analysis, cure rate at 4 weeks was 67% in the 40 mg/kg group and 90% in the 80 mg/kg group (absolute difference 23% [95% CI 14–31]; p<0·001), and the egg reduction rate difference was 2% (95% CI 1–3; p<0·001) based on geometric mean and 22% (95% CI 5–59; p<0·001) based on arithmetic mean. No severe adverse events related to the study drug were reported. At 12 months, biannual versus annual treatment reduced prevalence of fecal occult blood and 80 mg/kg dose reduced prevalence of elevated fecal calprotectin.
Conclusions: The 80 mg/kg dose is safe, well tolerated, and more effective in achieving parasitic cure than the current proposed 40 mg/kg dose. Until a pediatric formulation of praziquantel is widely available in endemic areas, the use of crushed tablets with this dosing strategy can be recommended for young children living in S. mansoni endemic areas.
