Abstract
Better knowledge of the efficacy and safety of single-dose 40 mg/kg oral praziquantel in preschool-age children is required, should preventive chemotherapy programs for schistosomiasis be expanded to include this age group. We analyzed individual participant-level data from 16 studies (13 single-arm or cohort studies and three randomized trials), amounting to 683 preschool-age children (aged <6 years) and 2,010 school-age children (aged 6-14 years). Children had a documented Schistosoma mansoni or S. haematobium infection, were treated with single 40 mg/kg oral praziquantel, and assessed between 21 and 60 days post-treatment. Efficacy was expressed as arithmetic mean and individual egg reduction rate (ERR) and meta-analyzed using general linear models and mixed models. Safety was summarized using reported adverse events (AEs). Preschool-age children had significantly lower baseline Schistosoma egg counts and more losses to follow-up compared to school-age children. No difference in efficacy was found between preschool- and school-age children using a general linear model of individual-participant ERR with baseline log-transformed egg count as covariate and study, age, and sex as fixed variables, and a mixed model with a random effect on the study. Safety was reported in only four studies (n = 1,128 individuals); few AEs were reported in preschool-age children 4 and 24 hours post-treatment as well as at follow-up. Three severe but not serious AEs were recorded in school-age children during follow-up. There is no indication that single-dose 40 mg/kg oral praziquantel would be less efficacious and less safe in preschool-age children compared to school-age children, with the caveat that only few randomized comparisons exist between the two age groups. Preventive chemotherapy might therefore be extended to preschool-age children, with proper monitoring of its efficacy and safety.
Highlights
The global schistosomiasis control strategy relies upon preventive chemotherapy with praziquantel, primarily targeting school-age children
Schistosomiasis is a diseases caused by helminths which affects the intestinal and urogenital systems
We collected individual-participant data from a series of studies in which 40 mg/kg of praziquantel had been given to children with intestinal or urinary schistosomiasis, and compared its efficacy and tolerability across age-groups
Summary
The global schistosomiasis control strategy relies upon preventive chemotherapy with praziquantel, primarily targeting school-age children. The current World Health Organization (WHO) guidelines are that preschool-age children should be treated on a caseby-case basis upon diagnosis of infection due to a lack of an age-appropriate formulation of praziquantel [5]. WHO is considering the inclusion of preschool-age children in preventive chemotherapy with praziquantel, should an appropriate formulation of praziquantel become available [5,6,7]. Evidence of efficacy and safety of praziquantel in preschool-age children is limited [5], and it is unclear whether they should receive the same dose (i.e., oral administration at a single dose of 40 mg/kg body weight) as their school-age counterparts, adolescents, and adults [10]. Better knowledge of the efficacy and safety of single-dose 40 mg/kg oral praziquantel in preschool-age children is required, should preventive chemotherapy programs for schistosomiasis be expanded to include this age group
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